Blood Bank Of San Bernardino And Riverside Counties
Blood product, with insufficient plasma to support the platelet yield, was distributed.
Blood Bank Of San Bernardino and Riverside Counties
Blood product, collected from a donor who reported post donation illness, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, not prepared in accordance with specifications, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced, Irradiated
Blood product, prepared from a whole blood unit that had an extended bleed time documented, was distributed.
Blood product, inappropriately stored in one platelet bag instead of two, was distributed.
Blood product, collected from a donor who had taken an aspirin-like medication, was distributed.
Blood product, collected from a donor who reported travel to an area that was endemic for malaria, was distributed.
Blood products, failed to meet specifications for product volume, were distributed.
Blood products, collected from a donor for whom there was no documentation of an arm inspection, were distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood product, manufactured without additive solution, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a previously deferred donor, were distributed.
Blood product, labeled as leukoreduced was not tested to verify the White Blood Cell count, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPCs - 073798001016
There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, posing a potential health/safety hazard.  The cap in question is no longer used by ABC and was last produced in September of 2011.  Firm does not anticipate finding any impacted product in the market.
Big Hug, Fruit Barrel Orange in a plastic 16 oz  bottle with a sports cap, American Beverage Corp., Verona, PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPCs - 074806001585
There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing), and then possibly ingested, posing a potential health/safety hazard.  The cap in question is no longer used by ABC and was last produced in September of 2011.  Firm does not anticipate finding any impacted product in the market.
Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap,  American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Lemonade, 018397000060
There is a possibility that a part of the nozzle cap of the bottle can become dislodged through abuse (i.e. excessive chewing) then possibly ingested, and posing a potential health/safety hazard.  The cap in question is no longer used by ABC and was last produced in September of 2011.  Firm does not anticipate finding any impacted product in the market.
Guzzler Concord Grape  20 fl. oz. PET plastic bottle with a sports cap,  American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Concord Grape, 018397000039
Guzzler  Island Punch 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Island Punch, 018397000015
Guzzler Iced Tea 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavorand UPC code: Iced Tea, 018397000077
Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Kiwi-Strawberry, 018397000022
Guzzler Alpine Freeze, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Alpine Freeze, 018397000091.
Guzzler Orchard Chill, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Orchard Chill, 018397000107
Guzzler Citrus Punch, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
The following product bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   Flavor and UPC code: Citrus Punch, 018397000138
Big Juicy Blue Raspberry Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY.
Big Juicy Grape Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170014.
Big Juicy Orange Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170007.
Big Juicy Fruit Punch Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY, UPC code 074806170021.
Big Hug Fruit Barrel Grape in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC- 074806001592
Big Hug Fruit Barrel Fruit Punch in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC- 074806001608
Big Hug Fruit Barrel Citrus in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC- 074806001691.
Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC- 074806001622
Big Hug  Lemonade Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC-  074806001639
Big Hug Lemon Lime Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC-  074806001653
Big Hug Fruit Barrel Blue Raspberry in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC- 074806001615
Big Burst Grape Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC -073798001023
Big Burst Lemon Lime Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC - 073798001054
Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC-073798001030
Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC-073798001092
Big Burst Kiwi Strawberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC-073798001207.
Big Burst Citrus Punch Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Products bearing a ''best buy'' or ''expiration date'' earlier than 09/24/12 ONLY:   UPC -073798001108
Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.
1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected.    2) When patient data on a vertical chart exceeds one page (with more rows then can fit on a page), the thumb indicator (Right Scroll Bar) appears to be at the end of the page when there may be more data. Because this information is not viewed, the clinician may not take the data into account when making a clinical decision. However, the bottom right corner of the chart box is displayed when you reach the end of a vertical chart as a visual cue.     3) It is possible for a system manager to misconfigure a coded or multi-coded item with no short text defined. This may have the effect of not presenting the data on the tubular chart display even if the data is set to show long text values. The clinician may not be aware this data exists and therefore may not take into account during clinical decision making.     4) If using a Phillips physiological monitor (not fetal monitor) at a patient's bedside, and data still exists on the monitor from the previous patient, and the clinician selects the ''acquire vital signs'' action from the Centricity Perinatal system before the initial vital signs are actually taken on the new patient, the monitor buffer sends the last set of vital signs from the previous patient. This data may be stored in the patient record if vital signs do not need to be validated. If this incorrect data is stored to the patient record the clinician may use this data in clinical decision making.     5) The Centricity Perinatal server process (PTD) that manages scheduled tasks may be misconfigured and saved with undefined patient selection criteria. When the criterion for a PTD job is undefined (selected patient or sele
Worldwide Distribution - USA (nationwide) including GA and Internationally to Canada and the United Kingdom.
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.   The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the master panel is blank instead of null or the panitem specimen group field of one or more of the ordered items on another re-route master panel on the same request is blank instead of null, and; 3) The re-routed batches containing the affected master panels are recieved at the performing lab before the item causing the reflex is resulted.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.  Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
1) List Number 13000: 2,162 pumps; 2) List Number 13100: 15 pumps; 3) List Number 13150: 1,955 pumps
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:    1) Cassette Check - D;   2) Cassette Check - P;   3) Proximal Occlusion;   4) Distal Occlusion;   5) Pressure Calibration Error;   6) Bad Pressure Sensor Event;   7) Bad Pressure State;   8) Distal Pressure is Out of Range;   9) Proximal Sensor is Out of Range.     A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Worldwide distribution: USA (nationwide) and the country of Canada.
Olympus Endoscopic Flushing Pump, Model OPF-2.   Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
There is a possibility that the pump head was not shipped in the locked position.  If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Multiple lots affected, with expiry dates through 22-Mar-2015
16732 units  (12208 units domestically & 4524 internationally)
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
544 units (48 domestically & 496 internationally)
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
16583 units (3073 domestically & 13510 internationally)
VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
28501 units (20321 domestically & 8180 internationally)
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
183267 units (89415 units domestically & 93852 units internationally)
VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
24322 units (12329 units domestically & 11993 units internationally)
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
70,125 units (20,219 units domestically & 49,906 units internationally)
VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
197,552 units (88,537 units domestically & 109,015 units internationally)
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
74,792 units (35,501 units domestically & 60,291 units internationally)
VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204  VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
31,0947 units (139,602 units domestically & 171,345 units internationally)
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
231,112 units (133,173 units domestically & 97,939 units internationally)
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
11,135 units (153 units domestically & 10,982 internationally)
VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829  VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
28,855 units (12,472 units domestically & 16,383 units internationally)
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
86,503 units (30,378 units domestically & 56,125 units internationally)
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
28,739 units (480 units domestically & 32,739 units internationally)
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
12,484 units (9,040 units domestically & 3,444 units internationally)
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.  VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
364,752 units (148,285 units domestically & 216,467 units internationally)
VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
86,522 units (30,717 units domestically & 55,805 units internationally)
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
24,857 units (17,887 units domestically & 6970 units internationally)
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
100.393 units (36,873 units domestically & 63,520 units internationally)
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
205,534 units (137,887 units domestically & 67,647 units internationally)
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
37,525 units (11,898 units domestically & 25,627 units internationally)
VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
349,072 units (142,455 units domestically & 205,617 units internationally)
VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
28,633 units (14,634 units domestically & 13,999 units internationally)
VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
62,039 units (5,974 units domestically & 4,702 units internationally)
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
62,039 units (26,765 units domestically & 35,274 units internationally)
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
101,976 units (39,909 units domestically & 62,067 units internationally)
VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
6,606 units (5,071 units domestically & 1,535 units internationally)
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
81,382 units (28,256 units domestically & 53,126 units internationally)
VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
21,163 units (16,218 units domestically & 4,945 units internationally)
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
19,438 units (8,845 units domestically & 10,593 units internationally)
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
15,492 units (11,870 units domestically & 3,622 units internationally)
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
175,689 units (86,745 units domestically & 88,944 units internationally)
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
7,926 units (6,026 units domestically & 1,900 units internationally)
VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
127,662 units (42,487 units domestically & 84,906 units internationally)
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
31,395 units (10,864 units domestically & 20,531 units internationally)
VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
85,646 units (13,640 units domestically & 72,006 units internationally)
US Distribution in the states of: AZ, FL, and TX.
Polyglycolic-Lactic Acid Absorbable Surgical Suture   Label reads in part ''Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***''    PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
Blood product, collected from a donor who reported travel through a malarial endemic area, was distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor who was previously deferred, was distributed.
US: Nationwide (AK, CT, FL, GA, IA, IL, IN, KS, MD, MI, MT, NC, NJ, NV, OH, PA, WI, WV)
Mixed nuts in a plastic bag labeled in part:    PREMIUM QUALITY; Terri Lynn Inc.; Deluxe Mixed; No Peanuts; NET WT. 16 OZ. (1 LB.) 454 g; P.O. BOX 5118 ELGIN, IL 60121
Item Number: 60025; Julian Code: 3180; Lot Number: MO-00551270
Terri Lynn Inc. ''Deluxe Mixed Nuts No Peanuts'' was found to have undeclared peanuts inside the bag.
Mixed nuts in a plastic bag labeled in part: Deluxe Mixed Nuts with Macadamia; NET WT. 12 OZ. (340 g), 30 LB, 35 LB; P.O. BOX 5118 ELGIN, IL 60121
12-oz.: Item Number: 09720; Best Buy Date: 12-29-14; Lot Number: MO-0551140; 30-lb: Item Number: 20062; Julian Code: 3203; Lot Number: MO-00554485; 35-lb: Item Number: 96004; Lot Number: MO-00550823
12-oz.: 56 bags (7 cases); 30-lb: 5 cases; and 35-lb.: 51.24 cases
Blood products, collected from a donor who previously tested positive for NAT, were distributed.
Platelet, with insufficient plasma volume to support the platelet yield, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Ergosafe Products LLC DBA Prism Medical Services USA
Medcare Products Max-500 Stand, Total Support, patient stand, model #400006.  The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN.   Used for assisting patients/residents to a standing position.
The lift might fail with the labeled 500-lb. load rating.
Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007.  The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN.   Used for assisting patients/residents to a standing position.
Worldwide Distribution-USA (nationwide) and the countries of  Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
ADVIA 1200 System Software: 1) V2.00, 2) V2.01.   Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
ADVIA 1650 System Software: 1) V4.01, 2) V3.52.   Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
ADVIA 1800 System Software V2.01.   Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
ADVIA 2400 System Software V4.01.   Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
St Mary's Hospital and Medical Center, Inc.
Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.
Blood product, collected from a donor with no documentation of an arm inspection, was distributed.
American National Red Cross (The) - North Central Region
Blood products, possibly contaminated with air, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood product, incorrectly identified as Jka negative, was distributed.
West Tennessee Regional Blood Center Inc
Blood product, with no documentation of QC testing for platelet pH, was distributed.
Blood products collected from a therapeutic donor with polycythemia, were distributed.
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY  10017, NDC 0025-1031-31
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Stryker Medical Division of Stryker Corporation
Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.
Model FL14E Rose  BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
4126 units USA; 20449 inits Internationally
It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
Lot Number 59627; Expiration Date 02/2014
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
*** 1) SYMBIQ One-Channel Infuser;  *** 2) SYMBIQ Two-Channel Infuser;    *** E09 batteries can be identified by the ''E09'' that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery;     *** E10 batteries can be identified by the ''E10'' that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery.    Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.
Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Nationwide distribution including Puerto Rico.
BIOMET Spine, Parsippany, NJ 07054. 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only.  Non-Sterile.   Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Polaris Translation Screw Failures were recently reported to Biomet Spine.  These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.
Steakhouse Parmmesan Topping was produced on the same equipment line as another product that tested positive for Salmonella.
US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50    dental adhesive for restorations
Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015
63 refill packs (50 single use applications per refill)
Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Derma-Smoothe/FS  (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida  32773, NDC 28105-150-04.
Multi Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle.  24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case.    Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''
275,342 bottles; 74,080  bottles(Club pack)
Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as ''Multi'' softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are losing potency more rapidly than initially expected, and these products are not meeting label claims for these vitamins throughout their shelf life.
Multi for Her (Full Strength Mini and Multi Softgels), 60 Count Bottle.    24 units per master case.    Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''
Multi for Her 50+ (Full Strength Mini and Multi softgels)    24 units per master case.    Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''
Multi For Him (Full Strength Mini and Multi Softgels), 60 Count Bottle.    24 units per master case.    Product labeling reads in part:''NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-2878 www.NatureMade.com***''
Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles.  The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
Expired active ingredient was used in the manufacture of the product.
Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD    Product usage:  Usage:  DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
Domestic: 1191 units; Foreign: 3052 units
Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems.  The System Specific Values (SSVs) for the Direct Bilirubin Assay (DBIL_2) have been reassigned for these lots. Siemens has determined that the DBIL_2 SSVs currently assigned to these lots may cause an average shift of +7-9 % in quality control and sample recovery at a level of 3 mg/dL. This Urgent Medical Device Correction provides reassigned values for the DBIL_2 SSVs for Chemistry Calibrator Lots 090445B and 090445C.
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
Lot #: 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Agway LS Meat Goat 16 PL (DQ) (AX) MEDICATED, Net Wt. 50 lb poly bags
Cargill Feed & Nutrition has recalled Agway LS Meat Goat 16 Pellet with Decox due to the presence of excessive amounts of selenium.
Worldwide Distribution - USA (nationwide) and Internationally to Nationwide and OUS countries include:  Australia, Austria, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, Switzerland, and the UK.
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001.  Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws.  The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine.  This system provides temporary stabilization and augments the development of a solid spinal fusion.  Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation.  The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach.  This system also features anti-migration locking caps to help secure the fixation screws.  All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V). The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.
Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots).  The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray.  This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle.
Worldwide Distribution-USA (nationwide) and the countries of  Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
GE Vivid E9 ultrasound system.  GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications.  The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers.  It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices.  It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system.  During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.
Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178
Krispak, Inc. is voluntarily recalling one lot of Spicy Sweet Mix due to a potential mislabeling, resulting in undeclared allergens. Good Sense City Mix  (contains: Peanut, Milk, Almond, Cashew, Soy) was labeled as Good Sense Spicy Sweet Mix (contains: Peanut, Milk, Wheat, Soy), resulting in the undeclared allergens of Almond and Cashew.
Worldwide Distribution - USA (Nationwide) and Canada.
Synthes Soft Tissue Retractor Small Extendible   Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.
Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
The products were distributed to manufacturers and distributors nationwide and to Canada.
Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com***
Lots: fsb-tw07  fsb-uw14  fsb-vw08  pob-tw31  pob-vw27  pob-xw23  pob-aw05  cbx-yw12  cbx-xw06  cbx-xw10  cbx-aw09  ccu-yw06
Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.
Pectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzyme blend for cyto grn, pectinase 150m, and Cellulase 3, packed in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com***
Lots: SYNAE-VW18  SYNAE-VW19  SYNAE-VW20  BRI-XW16  E7X-TW03  E7X-UW20  E7XBY-UW21  E7X-WW26  E7XBY-XY07  E7X-YW25  E7X-ZW24  E7X-BW16  PE003-UW21  PE003-XW02  EBY2X-UW22  EBW-VW12  EBW-VW13  EBW-VW14  EBW-XW10  EBW-XW13  EBW-XW14  EBY2X-XW15  EBW-YW11  EBW-YW12  EBW-YW13  EBW-AW19  EBW-AW20  PE350-VW01  PE350-YW19  EBW-AW21  pe05-ww30  ALI13249-03  ali13024-02  ali13036-01  ali13212-04  ali13157-09  bgb0111-vw26  db18-xw24  db18-yw04  db18-yw06  db18-aw22  DB18-ZW23  DB18-AW30  ec5763-bw06  pe035-tw23  peo35-tw14  pe1750-vw11  pe350-vw11  ECHPX-ZW18  pe350-xw22  pe350-aw13  ebcyto-yw28  ebcyto-aw09  ebcyto-bw19  pe150-vw20  pe150-bw05  cell3-ww18  cell3-xw07  cell3-aw01  cell3-AW14  pe01-uw07  pe035-yw07  EB7-XW08  EB7-AW23
Xylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7 multi-enzyme blend  EB110311-01, EB020812-01, xylanase 70,000, nut 14-500, ultra blend 102  xylanase 10,000, bb cd blend #3, soy blend, amiron blend, Formula #121412b, erc530b, pn digestive blend, digest basic, blend 0313, xylanase 20,000, EC-CHPX, Xylanase 50,000 XU, Xylanase 50m XU, Xylanase 25,000, Xylanase 190,000 XU, af-5x, silage blend, xylanase concentrate, Enzyme Blend 1, and Enzyme Blend 2, packed in boxes or drums ranging from 1 kg to 25 kg, item # XYXP, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com***
Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.
ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft,  REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect.  The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
65 handpieces (Domestic: 41 devices; Foreign: 24 devices)
The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed.  ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.
ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft,  REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
147 handpieces (Domestic: 135 devices; Foreign: 12 devices)
Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade   Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
Worldwide Distribution - USA Nationwide in the countries of:  Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma;    Product Usage:  Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
515 in US. 315 International.(included all packaging configurations)
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers.  Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit  FP -23267): and  ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267).  RX.    Product Usage:  Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
515 US, 315 International (all packaging configurations)
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067;  Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999):     Product Usage:  Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
515 US, 315 International (all packaging cnfigurations)
ARTAS  Disposable  and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538  Rx):    Product Usage:  Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
515 US, 315 International (all Packaging configurations.
Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand.   Product also sold to in 2 lbs. and 3 lbs. to restaurant.    Product is labeled in parts: ''***Organic Goat Dairy***Chevre***SUNNY PINE FARM***6 oz***Pasteurized Organic Goat Milk, Salt, Rennet, and Culture***Keep refrigerated***Handcrafted in Twisp, Washington 98856***.
Expiration dates of products sold to non-restaurant consignees: 10/16/2013.   Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13.      Chevre cheese products sold at Methow Valley Farmers Market (aka Twisp Farmers Market) between 7/27/13 and 10/12/13 were NOT labeled with an expiration date.
121/6 oz. packages.; 2/2 lbs. packages; 11/3 lbs. packages
Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Chevre due to possible improper pasteurization.
Organic Parsley Chive Chevre sold to non-restaurant in plastic 6 oz plastic tub vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand.   Product sold to restaurant is in 1 lb. and 2 lbs. size.    The product is labeled in parts: ''***Organic Goat Dairy***Parsley Chive Chevre***6 oz. ***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Salt, Parsley, Chives, Rennet, Cultures***Keep refrigerated***''
200/6 oz. tubs; 1/1 lb. package; 2/2 lbs. packages
Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Parsley Chive Chevre due to possible improper pasteurization.
Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand.   The product is labeled in parts: ''***Organic Goat Dairy***Honey Lavender Chevre***6 oz.***SUNNY PINE FARM***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Honey, Salt, Lavender, Rennet, Cultures***Keep refrigerated***''.
Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Honey Lavender Chevre due to possible improper pasteurization.
Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants.   However, the retail label is read in parts: ''***Organic Goat Dairy***Black Pepper Garlic Chevre***6 oz***SUNNY PINE FARMS***Handcrafted in Twisp, Washington 98856***Pasteurized Organic Goat Milk, Garlic, Pepper, Salt, Rennet, and Cultures***Keep Refrigerated***''.
Expiration dates of products sold to restaurants: 10/23/13 and 11/5/13.
Sunny Pine Farm of Twisp, Washington is voluntarily recalling Organic Black Pepper Garlic Chevre due to possible improper pasteurization.
Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
Cougar Nitinol Workhorse Guidewire: Models:  CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S     Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
THUNDER  Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
ProVia CROSSING GUIDEWIRE; Models:  15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.  Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a  target lesion. Medtronic guide wires are not intended for cerebral vasculature.  Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688   The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another
THUNDER  Steerable Guidewire; Model: LVTNDR190S   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S   Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
Brilliance iCT Computed Tomography X-Ray System,      Product Usage:  The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
Fixed Offset Adapter, A-642100.   The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
Item Number:  A-642100      All Serial Numbers.
Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
US states: KS, MN, HI, OH, CA, GA, NY, MO, OR, UT, TX, and Washington D.C.
CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case.   Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer.    Product labeling reads in part:''C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS CO., LTD.***PRODUCT OF THAILAND NET WT:14OZ(400 G)***''
UPC Code 8 851381 561145.  No Lot Codes or Best By Dates. The product only has a UPC code for the public's identification purposes.
The recall has been initiated due to missing ingredients not being shown in the ingredient list of the packaging. The missing ingredients are: Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1.
EDGE, Item number 21-620, dietary supplement, 60 packet per box.   The Edge product includes two different packets of capsules - a ''Before'' packet and an ''After'' packet.      The suggested use for the After packet is one packet (or 6 capsules) per day.  The suggested use for the ''Before'' packet is one packet (or 4 capsules) per day.
Lot BO1 and AO1, Expiration date Aug 2015
EDGE dietary supplement product is recalled because the finished label does not declare shark cartilage.
Flex, Maximum Flexibility,  Item number 21-601, dietary supplement, 90 capsules per bottle.   The Flex product is a dietary supplement in capsule form containing vegetable glucosamine HCL, chondroitin sulfate (shark cartilage), organic microalgae (aph. flos-aquae) and chicken cartilage.      The serving size is 3 capsules and the suggested use is one 3 capsule serving per day.
Lot EY1, manufacturing date of 8/2013. (product expires by August 2015)
Flex dietary supplement product is recalled because the finished label does not declare shark cartilage.
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and UNITED KINGDOM.
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615.   The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components
GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging.   Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery  NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients arms are positioned above the head and when dedicated safety armbands are not utilized.
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered,    Product is manufactured by Carl Zeiss Meditec AG (Jena),  Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA    This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
The user database delivered for download contained an erroneous value. Specifically the ''aO'' constant of the lens AMO Sensar AR40E is listed as ''0.0'' in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,    Product is manufactured by Carl Zeiss Meditec AG (Jena),  Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA    This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
USA Nationwide Distribution in the states of VA, CA, Ky, and IN
Juggerknotless Drill Bit, REF 110003173,  Sterile, Single Use    Product Usage:  The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone.  The implant may skip across the hole or miss the hole during insertion.
Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain, Iraq, Egypt, and Turkey.
Stryker 1)  XIA Torque Wrench  2) XIA 3 Torque Wrench  3) XIA Elegance Short Torque Wrench    Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30  http://www.stryker.com    Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000    XIA 3 Spinal System- Intended for use in the noncervical spine. When used as an anterior/anterloateral and posterior, non cervical pedicle and on-pedicled fixation system, the XIA 3 Spinal system is intended to provide additional support during fusion autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities; degenerate disc disease (DDD) ; spondylolisthesis; trauma spinal stenosis; curvatures; tumor; pseudoarthrosis and failed previous fusion. XIA - Intended for anterior/anterolateral and posterior, non cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease; spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.
Medical Device Listing Number E207315    1)  XIA Torque Wrench  Catalog # 03807028  Lot # 127510    2) XIA 3 Torque Wrench  Catalog # 48237028  Lot # 11E042, 11E044, 11E047    3) XIA Elegance Short Torque Wrench  Catalog # 482397028  Lot # 11A957, 11E035, 11E036, R11E036
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Philips Medical Systems North America Inc.
Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of  Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202.   Intended for diagnostic ultrasound imaging and fluid flow analysis.
284 units total (183 international; 100 in the US).
A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).
US: nationwide.   OUS: Australia,,Taiwan, England, Portugal, Denmark, Hong Kong, Bahrain, Thailand, Ireland, France, Poland, Macedonia, Brunei, United Arab Emirates, Israel,   Japan.
Swanson, Premium Brand,  Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.
Swanson Health Products is recalling two lots of  Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel.  Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359)  have been found to contain White Cumin Seed (Cuminum cyminum).
US Distribution in the states of: NC and CA.
Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, ''***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***''    The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries
Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO  64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 68546-317-30, UPC 3 68546 31730 4.
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
US states: PA, NJ, TX, CA, NY, FL, NV, OR, WA, OH, MI.
Best in Nature Brand Eye Care Essence, 100 Capsules.   Product labeling reads in part:''Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***''.
Lot Number 8956. Expiration Date 03-2016. UPC Code 8 92418 00109 6.
The firm initiated this recall in response to FDA sample findings that major ingredients are omitted partially or entirely. The product did not contain the amounts as labeled for Vitamin A and Vitamin C.
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU   Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Trader Joe's Southwest Salads, 9oz.   Packaged in plastic clamshell with ranch dressing packaged in plastic sealed solo cup.    Product labeling reads in part:''TRADER JOE'S ***SOUTHWEST SALAD with Black Beans, Corn, Cotija Cheese and a tangy Ranch Dressing***NET WT. 9 OZ (255g)***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S MONROVIA, CA 91016***''.
World Class Distribution of Fontana, California is voluntarily recalling one specific lot of Trader Joe's Southwest Salad (SKU 56077) with Use by Date 11/2/13 due to undeclared soy.
Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN  55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN  55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI  49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL  60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio  45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio  45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL  33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD  20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Libert
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio  43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL  60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio  45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX  78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ  07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC  28147/Scarborough, ME  04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA  94104, NDC 62011-0002-1, UPC 0 52569 13248 7
Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL  60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI  49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA  17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL  60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio  45202, NDC 30142-766-16, UPC 0 41260 35830 2
Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ  72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH  43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL  60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL  60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio  45202, NDC 30142-946-16, UPC 0 41260 35832 6
US Distribution: in the states of: Arizona, California, and Ohio.
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT.     Product Usage:  Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Note: These devices do not support or sustain life. Diagnostic EP Catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables interface an EP catheter with the appropriate external stimulation or recording equipment or serve as an extension cable between an EP catheter and equipment out of immediate reach. Reprocessed diagnostic electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
Northern CA and NV (Reno and Carson City)
Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated.  Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell.    Manufactured for Trader Joe's  Manufactured by Ghiringhelli Specialty Foods, inc.  Vallejo, CA 94950.
Report of mislabeled Caesar Salads with a use by date of 11/3/13 due to undeclared allergens of soy, fish and wheat on the ingredient and allergen statement.
Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and  MS.
Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road,  Arvin, CA 93203.    CO2 sample line.
It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00.     BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
37 units (19 in the US and 18 International)
Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00.  The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening  hardware in an absorber.
Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390.  It is a patient monitor with arrhythmia detection or alarms.   The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
54 units total (42 units in the US and 12 outside US)
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping carton can place pressure on the package, which can lead to damage and leakage.
Dura Guard, Dural Repair Patch with Apex Processing.   For use as a dura substitute for the closure of dura mater during neurosurgery.    Product Code:    DG0209SN    DG0209SN     DG0209SN    DG0209SN     DG0209SN      DG0209SN      DG0209SN     DG0209SN     DG0404SN       DG0404SN       DG0404SN      DG0404SN      DG0404SN      DG0404SN      DG0404SN       DG0404SN      DG0404SN   DG0404SN     DG0404SN     DG0404SN    DG0404SN       DG0404SN      DG0404SN     DG0608SN      DG0608SN       DG0608SN      DG0608SN     DG0608SN    DG0608SN       DG0608SN       DG0608SN       DG0608SN      DG0608SN      DG0608SN     DG0608SN     DG0608SN        DG0608SN        DG0608SN    DG0608SN      DG0608SN      DG0608SN      DG0608SN
Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE,   Model number: 9914-00-9040
Unintended single pulse  maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
US and  Canada, Germany, Great Britain, Hong Kong, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea , Spain
Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement.  10 tablets/Packet and 30 packets/1000cc bottle.    Distributed by:  Mark Rosenbloom, MD  LIFEFORCE Medical Institute  60 Revere Dr., Ste. 820  Northbrook, IL 60062  (847) 905-9505  www.lifeforcemed.com
Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol.
Pro Thera Dual Detox Dietary Supplement; 60 capsules;   Chlorella - 500 mg;  Broccoli Sprout, dried extract - 60 mg;  Enzyme Blend - supplying Beta-Glucanase, Cellulase, Protease, Hemicellulase, Phytase and Xylanase    Manufactured by ProThera, Reno, NV,
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1