Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution was nationwide.  There was also government and military distribution.  There was no foreign distribution.
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075),   Product Usage:  Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
The following lot numbers are affected and are not specific to each cable/sensor type:      09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB,  and 12FMH.
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor,  finger clip pediatric (Merge Part Number: HW-HEMO-00076),   Product Usage:  Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014),    Product Usage:  Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047),     Product Usage:  Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of :  AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA,  WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform  calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
International Flavors & Fragrances, Inc.
Seasoning blends    IFF Inc. Carrollton  1620 West Crosby Carrollton TX 75006  Net Weight 50.00 LBS 22.680
Seasoning blends may contain salmonella.
Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong,  Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South  Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, Zimbabwe
Access Total T3, A34435H, Catalog No. 33830
313,158 units total (43,725 units in US)
The Access immunoassays are susceptible to biotin interference.
Access Thyroglobulin, A34085G, Catalog No. 33860
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Access System-Free T4 Assay, B01902E, Catalog No. 33880
1,154,084 units total (167,035 units in US)
Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution ---    The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Domestic: 1449 units; Foreign: 1416 units
Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process.  This could result in separation of the tube and yoke assembly.
Serial Numbers: Worldwide except China:  101 through 2623; China only:  800101 through 800482
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
The American National Red Cross - Southern Region
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
American National Red Cross (The) Carolinas Region
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood products, which did not meet the acceptable product specifications, were distributed.
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
De Mi Pais, Queso Fresco, Whole Milk Cheese, Net Wt 16 oz.. (1 lb)
Product contaminated with Listeria monocytogenes
Queso Fresco x LB (Barra)/ Whole Milk Cheese, Net Wt 5-6 lbs.
Product is potentially mislabeled and contains the non-dietary ingredient Picamilon.
Mr. Hyde Green Apple; Mr. Hyde Green Apple Sweden
Mr. Hyde Watermelon (V2); Mr. Hyde 30 Watermelon
Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domestic Fruit Punch
High Frequency Resection Electrodes, endoscope, ac-powered and accessories  The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Nationwide Distribution to  facilities and distributors.  Distribution was made to the Virgin Islands.  Foreign distribution was also made.  There was no military/government distribution.
Merge LIS software.  The firm name on the label is Merge Healthcare.    Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
638 sites have the potentially affected versions
There are potential issues with results reporting for certain run-based tests.  Under certain conditions, the wrong results could inadvertently be verified.
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector  Item Code: 173019  The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
Cotton tip of the device may disengage due to insufficient adhesive
Lot Numbers: M5K04X to M7A01X  Exp Date: 2020-October through 2022-January
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
American National Red Cross Great Lakes Region
Lifesouth Community Blood Centers - Montgomery Region
Blood product, which was labeled with an incorrect volume, was distributed.
Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI,  MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii  Foreign:  Canada and Japan
SHIMADZU FDR Visionary   Catalog Number: FDR Visionary Suite  Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M  Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro;  Stationary x-ray system
Product was shipped to the following states: AL, AR, GA, IL, IN, KS, KY, MI, MO, MS, NC, NE, OH, SC, TN, VA & WV.
Kroger Dessert Cups yellow sponge cakes NET WT 6.5 oz (184g) INGREDIENTS: ***NONFAT M ILK***CONTAINS: WHEAT, EGGS, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 800-632-6900 www.kroger.com UPC 0 11110 18550 1
BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
Severn Peanut Co., Inc. DBA Hampton Farms
Direct to one consignee in NJ.  Further distributed to: New Jersey, New York, Pennsylvania and Connecticut.
Avas 8 oz. Organic Roasted Unsalted Cashews UPC 8-10111-01036-8
fewer than 675 units total for all products
Product may be contaminated with Listeria monocytogenes.
Avas 8 oz. Organic Roasted Unsalted Almonds UPC 8-10111-01032-0
Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs, UPC 8-10111-01035-1
Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
da Vinci Xi Surgical System    Product Usage:  The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Mindray DS USA, Inc. dba Mindray North America
TI Transport Monitor/Module Battery Pack    Product Usage:  intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
3m Center 2510 Conway Ave , B# 275-5-W-6
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979    The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
Whole Foods Cranberry Couscous- packaged in Clear plastic clamshell for 6oz, 14oz and 18oz, and white plastic pail for 10lb.  UPC Codes: 036217162613(6oz),  036217162514(14oz), 036217261408(18oz), 036217110317(10lb)
Product contains undeclared  tree nuts-cashews
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
Failed Moisture Limits: Product tested out-of-specification for moisture content.
LEGION(R) FEM CONE IMPACTOR HEADS:  a) REF 71441976, ID 18MM  b) REF 71441977, ID 20MM  c) REF 71441978, ID 22MM
The incorrect Loctite adhesive was used to assemble the impactor heads.
Lot numbers:  a) 16HGA0031  b) 16HGA0034  c) 16HGA0035
LEGION(R) TIB CONE IMPACTOR HEADS:  a) REF 71441972, ID 24MM  b) REF 71441971, ID 22MM  c) REF 71441973, ID 26MM  d) REF 71441974, ID 28MM  e) REF 71441975, ID 30MM
Blood products, for which donor screening was performed incorrectly, were distributed.
US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and  Washington.
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached.  Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
ROTH Catalogue Numbers 14002 96 S and 14002 25 S only,
Kroger Corporate Food Technology Laboratory
BAKEHOUSE BREAD ARTISAN CRANBERRY ORANGE BREAD, 16 OZ UPC 8 64934 00004 4 Bakehouse Bread Company Tucson, AZ
The firm was notified by a customer that the label does not include Pecans or Tree Nuts in the Allergy contain statement.
Pointe Scientific Liquid Creatine Kinase Reagent Set  Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Linear performance information in product insert does not match that listed in the approved premarket notification
Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV.  Foreign Distribution to CHILE
Pointe Scientific CRP(HS) Wide Range Control Set and  Pointe Scientific CRP(HS) Wide Range Standard Set  5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are  incorrectly listed as mg/dl when the correct unit is mg/L.
The Pointe Scientific CK-MB Isoenzyme Control  Pointe Scientific CK-MB Level II Control,  C7562-12 Control Kit
Incorrect control range in product labeling
Model C7562-12 Control Kit.  Lot: 013206-260, Expiration Date: 2013-03
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186.  NDC: 68968-6610-8
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Nationwide in the USA, Puerto Rico, and the United Kingdom.
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.,  Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
Superpotent Drug: high out-of-specification result for magnesium.
Nationwide Distribution to MD, NY, and IL
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO,    Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
Lack of sterility assurance.  There is a defect in the primary packaging of the device, which may compromise the device sterility
Shirakiku Brand Red Bean Ice Cream 3 gallon foodservice tub
Firm is recalling a limited number of Green Tea and Red Bean ice cream due the possibility of the presence of metal fragments.
Green Tea Ice Cream:  Sold under the brand names of:  Trader Joe's Brand Matcha- 1 quart tubs, SKU 055740;  Shirakiku brand Matcha and Fukuya brand, both in 3 gallon foodservice tubs.
13, 210 cases Trader Joe's, 1945 cases Fukuya brand and 1237 cases Shirakiku brand.
Trader Joe's - All lots:  Shirakiku brand - Lots 119-17, 128-17;  Fukuya Brand - Lots 116-17, 117-17, 129-17.
Doxycycline Hyclate USP, active pharmaceutical ingredient,  a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8).  For Prescription Compounding RX Only.  Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK
Retention of Outdated Information in an Order Set.  In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
CGMP Deviations: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
IMPAX Cardiovascular  The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6