Talecris Plasma Resources Inc Dba International Bioresources
Blood products, collected from a donor whose annual physical exam was not performed, were distributed.
Blood products, collected from donors that used  the incorrect version of the BDR, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was previously HIV-1/2 reactive, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, stored without continuous monitoring and possibly exposed to unacceptable temperatures, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
California, Idaho, Oregon, Utah, and Washington.
Platelets Pheresis Leukocytes Reduced Irradiated
Platelets, possibly exposed to unacceptable temperatures, were distributed.
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
Community Blood Centers of South Florida, Inc.
Blood products,  collected from a donor who was previously deferred,  due to testing Anti-HTLV reactive, were distributed..
Blood products,  collected from a donor who was previously deferred,  due to testing Anti-HTLV reactive, were distributed.
Blood product, possibly contaminated with bacteria, was distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Red Blood Cells Leukocytes Reduced Washed
Blood products, possibly contaminated with bacteria, were distributed.
Blood products, which were possibly contaminated with peptostreptococcus, were distributed.
Blood product, labels applied to blood unit or product with incorrect and/or missing information, was distributed.
Blood products, collected from a donor, whose suitability to donate were not adequately determined, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product,  labeled with  incorrect or missing information, expiration date, was distributed.
Blood product, in which quality control did not meet specifications, was distributed.
Providence  Health System - Southern California
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Nationwide in the US: CA, OR, WA.   Africa.
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Blood products, which were collected from a donor who had received a ear piercing within 12 months of the donation, were distributed.
Blood products, collected from a donor who received tattoos within 12 months of donation, were distributed
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
Beef Bully Sticks were distributed to Target locations in: AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, WI. Chicken Jerky Treats were distributed to 57 Sam's Club locations in: CO, IA, ID, IL, KS, MO, MT, NE, OK, SD, UT, WY.
Boots & Barkley American Beef Bully Sticks, 6 count, UPC 647263899189, Distributed by Target Corporation Minneapolis, MN 55403, Target Brands, Inc. Made in the U.S.A. Promotes Plaque and Tartar Reduction; packaged in transparent flexible plastic with a folded paper label enclosed with staples.  The label is white, red and blue with black, white, red, and blue print writing and a photograph of a black and white dog.
Best By dates of 20APR2014 DEN to 03OCT2014 DEN.
Kasel Industries is recalling Boots & Barkley American Beef Bully Sticks, 6 count, due to possible contamination with salmonella bacteria.
Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, Best By ''091913 DEN'', Division of Kasel Industries, Denver, CO 80205.  Packaged in a transparent, flexible, plastic bag; the bag is yellow with black and white print writing and a photograph of a golden retriever dog on it.
Kasel Associated Industries is voluntarily recalling a specific lot of Nature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, due to possible contamination with Salmonella bacteria.
Boots & Barkley Roasted American Pig Ears, net wt 12 oz, 12 count, UPC 647263899158. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403.
Kasel Associated Industries is voluntarily recalling a specific lot of Boots & Barkley Roasted American Pig Ears, due to possible contamination with Salmonella bacteria.
Boots & Barkley, American Variety Pack Real Beef & Pork Treats for Dogs, net wt 32 oz., UPC 490830400086;  Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403,  Packaging is white, blue and red with red, black and blue print writing.
Kasel Associated Industries is voluntarily recalling a specific lot of Boots and Barkley American Variety Pack, due to possible contamination with Salmonella bacteria.
Worldwide Distribution including the countries of UAE (United Arab Emirates)  HONG KONG and THAILAND.  Not distributed in USA
Sarns '' TCM II Temperature Control Module   The Sarns'' TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Internal testing found certain Sarns'' TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
CA, FL, HI, IA, IN, KS, MD, MI, MN, MO, MS, NE, NJ, NM, OK, OR,  PA, TN, TX, WI,  Firm also distributed to PR and Korea
Ivermectin/pyrantel flavored chewables for dogs up to 25 lbs., each tablet contains 68 mcg. ivermectin and 57 mg. pyrantel as pamoate salt, RX, ANADA 200-302,  packaged with the following brand names and configurations:    (1) Virbac Animal Health Iverhart Plus Flavored Chewables, packaged 6 tablets per box, 10 boxes per display, product #0170DS.  Manufactured by: Virbac AH, Inc., Fort Worth, TX;     (2) Wormshield Flavored Chewables Hannah Pharmaceuticals, packaged 6 tablets per box, 10 boxes per display, product #0210DS. Manufactured for: Schuyler LLC, Portland, OR; and     (3)Virbac Animal Health Iverhart Plus Puppy Pac, promotional Information packet containing 1 tablet, product #01800.  Manufactured by: Virbac AH, Inc., Fort Worth, TX;
Iverhart Plus and Wormshield lots:120844 and 120196: Puppy Pac lot 120844 only
Firm testing found recalled lots to be out of specification with sub-potent results.
Worm Shield (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs.  Hannah Pharmaceuticals Manufactured for Schuyler LLC Portland OR
Product number 0210DS - lots:120844 and 120196
Product number 0210DM - lots:120202 and 120845
Iverhart Plus (ivermectin/pyrantel) Flavored Chewables to prevent heartworm disease and control ascarid and hookworm infections in dog
Interstate Blood Bank, Inc. of Wisconsin
Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.
Worldwide Distribution - US Distribution  including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
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.
If environment variables  MICRO_CORRECT_MSG_TYPE  and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variables set to different values.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who was previously deferred for a positive HIV test result, were distributed.
Blood products, collected from a donor who reported a post donation illness, were distributed.
Blood products, collected from a donor who lived with a hepatitis positive individual, were distributed.
Blood products, collected from a donor who lived  with a hepatitis positive individual, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Switzerland; Austria; North Carolina; Missouri; Colorado
Blood products, collected from a donor whose sexual partner had a history of hepatitis B, were distributed.
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
Labeling Wrong Barcode;  It may display wrong product code reflecting  0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Human Corneas, recovered from a donor whose donor eligibility determination was incomplete related to evaluating  the donor's clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Blood Grouping Reagent, Anti-S (Monoclonal)
Seraclone Anti-S, with a decreased reactivity in two lots numbers, was distributed.
Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems.    Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse.     Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bolus tracking scan, typical real time information is not displayed to the user.  The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus.      And, if the operator is running a bolus tracking scan at the time the anti-virus is scheduled to run and the operator ignores or is not aware of the McAfee VirusScan Notification message displayed on the screen, typical real time information will not be displayed to the user.  The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus.
Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060   QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models.  This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
Blood products, collected from an ineligible donor, were distributed.
4R1583 ''CPD/ADSOL DBL Flex-Excel/Sample Diversion SYS/PL146/PL2209 500 mL''
Blood-Pack Units, with missing labeling on the satellite bags, were distributed.
4R3307E CPD/DSOL DBL WB RS-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146
4R3325E CPD/ADSOL TPL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146
4R3329E CPD/ADSOL DBL WB RS-2000 W/FENWAL Express System/Sample Diversion SYS 500 mL PL146
4R3340E CPD/ADSOL TPL WB RZ-2000 W/FENWAL Express System/Y-Sampling Site 500 mL PL146
Hot Dog Buns  8 Count Earthgrains Baking companies, Inc.  Horsham, PA 19044
Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery
Colonial Cookout Enriched Buns - 12 count   Earthgrains Baking companies, Inc.  Horsham, PA 19044
Colonial Party Pack Enriched  Buns - 12 count   Sara Lee, Downers Grove, IL 60515
Colonial Party Pack Sesame Seed Enriched Buns - 12 count   Sara Lee, Downers Grove, IL 60515
Colonial 12 Seeded Enriched Buns    Sara Lee, Downers, Grove, IL 60515
Great Value 8 Jumbo Hamburger Buns    Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716
Kerns Beef Buns - 12 count   Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210
Kroger White Jumbo Hamburger Buns - 8 Buns   Distributed By: The Kroger Co. Cincinnati, Ohio 45202
Kroger Sandwich Enriched Buns - 12 count   Distributed By: The Kroger Co., Cincinnati, Ohio 45202
Sara Lee Hearty & Delicious 100% Whole Wheat  8 Bakery Buns  Sara lee, Downers Grove, IL 60515
Sara Lee Classic White 12 Hamburger Buns   Sara Lee, Downers Grove, IL  60515
8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and  Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count    Sara Lee, Downers Grove, IL 60515
8 Bakery Buns Sara Lee Hearty & Delicious White    Sara Lee, Downers Grove, IL 60515
Sunbeam 12 Enriched Hamburger Buns  and   Sunbeam 12 (Seeded) Hamburger Buns    Earthgrains Baking companies, Inc.  Horsham, PA 19044
Foodservice 100% Whole Wheat Hamburger Buns - 12 Ct   Earthgrains Baking companies, Inc.  Horsham, PA 19044
Food Service Hamburger Buns Wheat with Oat 12 CT   Earthgrains Baking companies, Inc.  Horsham, PA 19044
Foodservice Hamburger Buns - 12 Count   Earthgrains Baking companies, Inc.  Horsham, PA 19044
Foodservice Hamburger Buns - 20 Count Earthgrains Baking companies, Inc.  Horsham, PA 19044
Hamburger Buns    Bimbo Bakeries USA  255 Business Center Dr.  Horsham, PA 19044    Food Service Hamburger Buns, Seeded and Unseeded, all counts:
Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA    MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Catalog Number: 10014432;   Lot Numbers:   1MQ310, Expiration Date: 31 Dec 2013,  2CQ310, Expiration Date: 31 Mar 2014,  2KQ310, Expiration Date: 31 Oct 2014
It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.
Worldwide distribution: US (nationwide) and country of: Canada.
Prism Medical C-Series Carry Bar, Class I, model number 360755.    The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.
BD SafetyGlide Allergy.  REF 305950 Sterile Allergy Treatment Syringe Tray.  The device is used for aspiration and injection of medications.
Catalog/Lot Number:  REF#305950 Lot 2132028 and Lot 2159189
There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
CoaguChek XS System (PST)   The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
CoaguChek XS Pro System   The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (''PT''), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
CoaguChek XS Plus System   The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
CoaguChek XS System (HCP)   The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Model/Catalog/Part Number: 04837975001 and 04625412160
Worldwide Disribution - USA Nationwide including Puerto Rico, and  the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,  Republic of Panama, Singapore, Spain and Venezuela.
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596,    Product Usage:  For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014).  The term GEN and Coating refer to specific segments of the reagent lot number.
While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990,    Product Usage:  For in vitro diagnostic use only. VITROS Chemistry Products 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.
GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013).  The term GEN and Coating refer to specific segments of the reagent lot number.
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation, Deerfield, IL  30015 USA.   Intended to isolate the Easy-Lock connector of the solution transfer set.
Products distributed in California, Missouri, and Oregon, and Wisconsin.
FLAV-R-PAC IQF Chopped Spinach, packaged in a  32 oz. bag, NORPAC Catalog #30238-01.  The UPC is 0 48800 30238 2   The product is labeled in parts: ''***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen until ready to use***Distributed by Norpac Foods Inc 4350 S.W. Galewood St. Lake Oswego, OR 97035-2499***www.norpac.com***''.
BEST BY FEB 2015/ 5F3 1248 19 HH:MM.   The code is interpreted as:    5F3 1248 19 HH:MM- Packed into Poly Bags on February 12, 2013  7:00am to 9:30am at NORPAC Foods Inc. Repack Plant #8 2210 Madrona Ave S.E. Salem. Oregon 97302-1112.    5 = Pkr; F = February: 3 = 2013; 12 = DD; 4 = Period; 8 = Plant #; 19 = Line #: & HH:MM = Time
IQF frozen chopped Spinach is recalled due to detection of elevated level of Cadmium.
Product was distributed to 8 domestic wholesalers/distributors and 1 foreign distributor.
SOGEVAL VETRICALM Soft Chews for Dogs Contact Sogeval Laboratories, Inc., Oldsmar, FL
Lot #008871 (60 count), expiration date 11/2013 Lot #008881 (120 count), expiration date 11/2013
Product's recent testing microbial analysis revealed results exceeding that of the upper limit of normal bacterial specifications.
INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL),  Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MO, NC,NV,NY, OH, PA, SC, TX, UT, VA, WA, WI, WV.
Enzyme Solutions, A Dietary Supplement,  Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.
Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing.  This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder.
Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132   orthopaedic
Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
Medtronic Sutureless Pump Connector Revision Kit, model 8578.  Contents:  catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps.  Contents of inner package are STERILE.   The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required.  The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port.
Product having a Use By Date prior to 25 Aug 2014
The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface.  Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.  Contents:  60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin.  Contents of inner package are STERILE.   The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port.
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC.  Contents:  81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors.  Contents of inner package are STERILE.   The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port.
Medtronic Intrathecal Catheter, model 8731SC.  Contents:  38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors.  Contents of inner package are STERILE.   The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port.
Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
TRUE Dilatation Balloon Valvuloplasty Catheter,    REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes:   20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm;     Intended to be used for balloon aortic valvuloplasty.
All lot numbers lower than PLN00749 are subject to this recall.
Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds.  The balloon normally deflates in less than 5 seconds.  The device performance specification for deflation time is 10 seconds maximum.
Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
Code Alert Advanced 4-Way Care Solution,  CA520 System, PN 9600-1600,  RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution .  Due to a firmware error, the alarm may not be transmitted to the system server immediately.
CMC Saddle   Product Usage:  The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.
As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.
Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device      Device Listing: D020871    Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased.  Baxter wants to ensure that no affected product remains in the field.
Brand Name: Coiled Tube Infusors. Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Two Day INFUSOR 2ml/h System, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bols Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor      Device Listing: D018045    The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications.
Distributed Nationwide and in Puerto Rico.
Brand Name: Infusor SV and LV Elastomeric Infusion Devices.   Indicated for the intravenous administration of medications.
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints.  Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
Brand Name: Multirate Infusor Devices.   Indicated for the intravenous administration of medications.
Brand Name: Regional Analgesia Infusor System with Patient Control.   Indicated for the intravenous administration of medications.
Brand Name: Intermate Infusion Pump.   Indicated for the intravenous administration of medications.
Brand Name: SV Elastomeric Infusion Device.   Indicated for the intravenous administration of medications.
Brand Name: Basal/Bolus Infusor.   Indicated for the intravenous administration of medications.
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound.   Indicated as an adjunct to mammography for breast cancer screening.
Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].
Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.
GE Healthcare Senographe Essential System.   The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.
GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
Worldwide Distribution - USA Nationwide and country of Canada.
Synchron System(s) Lactate Reagent   Product Usage:  Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or  storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.
Worldwide Distribution - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH, PA, PR, SC, TN, TX, UT, VA, WA, WY, WI, WY, and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK,, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLAND, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
CARESCAPE Monitor B850   Product Usage:    The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility  on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
GE Healthcare  become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve.   Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Medical devices were incorrectly labeled with extended expiration dates.
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060.   Used to facilitate placing a catheter through the skin into a vein or artery.
Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and  Chile.
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser.   The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser.       Manufactured by:  ConBio, A Cynosure Company  47733 Fremont blvd  Fremont, CA 94538
An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.
Worldwide Distribution -  US Nationwide including the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of:  AE, AU, AZ, BN, BR, CA, CH, CL, CO, DE, DK, DO, DZ, EG, ES, FR, GB, HK, HN, HR, HU, IN, IT, JO, JP, KR, LB, MU, MX, MY, NL, PH, PS, SA, SG, TH, TR, TW, UY, VE, and ZA.
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:    Product Usage:  Monitor, Physiological, Patient
The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.
Worldwide Distribution - US Distribution including the states of Delaware, Illinois, Minnesota , New York., Ohio and Pennsylvania and the countries of Germany, Turkey and France.
MAQUET GETINGE GROUP Arterial Cannula OD    Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
100 units (60 Domestic; 40 International)
The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
Medtronic Inc. Cardiac Rhythm Disease Management
Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to  Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom,  Uruguay , and Yemen,
Medtronic, Consulta CRT-P,  Model C4TR01, C3TR01 (not approved for US),  and Syncra CRT-P, Model C2TR01, Sterile EO.     Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specific Consulta and Syncra CRT-P devices and no other Medtronic device models are affected. This issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality.
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 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.
Internationally distributed: to countries of Germany and Poland.
Medtronic, Launcher Guiding Catheter,  Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD,  Lot # 0006724224, 6F   Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD,  Lot # 0006724224.
Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter.  The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and  ITALY.
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014.   Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product.  Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
240 stores and  10 See's licensees nationwide and 6 international retail stores.
See's Milk Raisins:   Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts    Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores.  UPC 7 37666 08306 0    Manufactured by: See's Candy Shops Incorporated  So. San Francisco, CA 04080
Potential for nuts and/or nut and egg residue may be present in some of the dark and milk chocolate covered raisins.
See's Dark  Raisins:   Ingredients: Raisins, Sugar,chocolate, cocoa butter, butter (milk), vanilla, soy lecithin,  Dextrin, Confectionery glaze.  May contain traces of eggs, tree nuts and peanuts.    Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores.  UPC 7 37666 08305 3    Manufactured by: See's Candy Shops Incorporated  So. San Francisco, CA 04080
BUPRENORPHINE HCl PF (C) INJECTABLE STRENGTHS:  0.15 mg/ml , 0.6 mg/ml  NDC:  49452825301, G9064-0122-10
Diamondback Drugs is recalling Buprenorphine HCL PF (C) Injectable due to an issue with the long-term stability of the product.  Use of the Buprenorphine HCL PF (C) Injectable may not deliver the level of therapeutic relief from pain as expected.
New Jersey, Pennsylvania, Delaware, Virginia, and Maryland
Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard.  Net Wt. 8.7 oz (247g).  Distributed by Wawa, Inc., Wawa, PA 19063.
Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling a limited quantity of Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard because they have the potential of containing an undeclared tree nut allergen.