Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI    Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Product Name: Orthosoft Universal TKR (software application)  Product Number: ORTHOsoft-UniTkr-2  Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA    Foreign: Canada, Australia  Austria  Brazil  China  Czech Republic  France  Germany  Israel  Italy  Lebanon  Luxembourg  Netherlands  New Zealand  Spain  Sweden  Switzerland  United Kingdom
Navitrack System - OS Knee Universal, Stereotaxic instrument
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42  due to software issues resulting in erros and discrepancies .
Part Number, Lot Number/Serial Number  ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3  ORTHOsoft-UniTkr- 2.1.6.0.2  OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA  Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA  Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA  Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA  Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA  Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA  and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of:  Germany, Turkey, and AU.
Wingman 35 Crossing Catheter, 65cm,     Model Numbers:   WGM35065US  WGM35065CE  WGM35090US  WGM35090CE  WGM35135US  WGM35135CE
ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
Trima Accel Automated Blood Collection System, Model No: CNs 81000, 81001, 81011, 81012
Spectra Optia and Trima Accel Automated Blood Collection System devices with a potential for a non-recoverable power failure, were distributed.
Spectra Optia Apheresis System, Model CN 61000, 61002.
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532,  NDC 51672-1254-3
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
449,661 units total (132,040 units in US)
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Platelet pool, lacking assurance regarding bacterial contamination risk, was distributed.
Co-component blood product, lacking assurance regarding bacterial contamination risk, was distributed.
Co-component blood products, lacking assurance regarding bacterial contamination risk, were distributed.
Distributed nationwide in U.S.A.,  Australia and Canada.
GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)
5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy      HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
8 vials total (6/10mL vials and 2/30 mL vials)
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
9 vials total (3/10mL vials and 6/50mL vials)
MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 INH PF GV  5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
86 vials total (78/5mL vials and 8/50mL vials)
TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only,  5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only,  10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ, Injection, 45.45mcg/27.27mg/0.45mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy
27 vials total (25/5 mL vials and 2/30mL vials)
HYDROXO-B12 5ML PBF MDV 1MG/ML INJ, Injection, 1mg/ml, Rx only, packaged in 5 mL Glass/ Multiple Dose and 30 mL Glass/ Multiple Dose vials,Prepared by Key Compounding Pharmacy
7 vials total (1/5mL vial and 6/30 mL vials)
GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL,  Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy      HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL,  RX only,  2 mL glass/ Single Dose vial.
50 vials total (10/1mL vials and 40/2mL vials)
TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection,  10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy
HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
PROCAINE HCL 50ML MDV (CALIF) 1% INJ,  Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only,  5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial  , Prepared by Key Compounding Pharmacy
PGE1 5ML MDV INJ,  Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials)
QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TESTOST AQ MDV  50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
6 vials total (5/5mL vials and 1/10mL vial)
PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection,  10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
CHOL/IN/ME(L)/B6 10ML MDV  50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
SODIUM BICARB 50ML MDV 8.4%  (2 MOSMOL/ML) INJ, Injection, 8.40%,  Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ,  Injection,  25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml,  Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
12 vials total (3/2mL vials and 9/10mL vias)
VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy
5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
CYCLOSPORIN (VET) *CORN OIL* 1% OPHTH, Ophthalmic, 1%, Rx only, 15mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL,  Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Blood products, lacking assurance regarding bacterial contamination risk, were distributed.
Nicarb 25% Type A Medicated Article 8.4 mg/kg     Distributed by : Phibrio Animal Health Corporation Teaneck, NJ 07666    NDC 66104-8200-0      Packed in a 50 lb./bag (22.68 kg/bag) Multi-wall bag with the following construction/configuration 4 ply Natural Kraft and 1 ply 0.8 mil HDPE
Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland,  Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194.    Intended for quantitative determination of salicylate concentration in human serum or plasma.
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625.    Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785.    Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
100,286 units total (20,732 units in US)
Triglycerides Reagent (TG 2 x 300), Catalog No. 445850.    Intended for quantitative determination of triglycerides concentration in human serum or plasma.
124,068 units total (47,920 units in US)
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825    Intended for quantitative determination of cholesterol concentration in human serum or plasma.
128,718 units total (47,858 units in US)
Lactate Reagent (LACT 2 x 50), Catalog No. A95550    Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298.    Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
Whole Foods single-serve Organic Vanilla Yogurt parfait cups with Strawberries and Granola, Various weights  PLU 58260
Sell by date between April 2, 2017 and April 11, 2017.
Proton therapy system -Proteus 235 aka Proteus Plus.    A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging  ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria    (Only 531640 was distributed in the United States)
Pointe Scientific Hitachi AST Reagent    R1 : PE plastic bottle w/PP plastic cap.  R2: PE plastic bottle w /PP plastic cap.    Product Usage:  Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
A Discrepancy was found on Hitachi AST (HA7 61) package insert.  Limitations section indicates linearity is 500 U/L and the Performance  section linearity is listed as 0-600 U/L, which is not consistent with the  510k submission package insert.
Magellan Diagnostics LeadCare Ultra Blood Analyzer    Part Number: 80-0010
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits  Part Number: 80-0010
US  OUS: Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium,  Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark,  Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia,  Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq,  Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia,  Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New  Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal,  Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia,  Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,  Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay,  Vatican, Vietnam, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany,  Denmark, Estonia, Spain, Finland, France, Great Britain, Hungary, Italy, Luxembourg, Latvia,  Netherlands, Norway, Greece, Croatia, Poland, Portugal, Romania, Sweden, Slovak Republic,  Turkey
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Blood and Blood Products for Reprocessing
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
SANTEE 30 Aquamarine Eye Pencil 0.04 oz/1g  13.3cm long x 0.9 cm in diameter, 288 dozens/case = 3456 units/case, UPC# 849609004848
Santee Cosmetics is recalling Santee Cosmetics Eye Pencil due to non-permitted color additive D&C Red No. 19 (Rhodamine B).
Blood Systems, Inc. dba United Blood Services Texas
Blood product, in which donor screening warranted deferral or follow up and was not deferred or follow up questions was not asked.
US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room.     Absorber Adapter Assembly Service Kit, part number: 050-9045-00.  Absorber Adapter Assembly, part number: 650-1648-01.  Arkon Absorber Canister Carrier, part number: 380-0916-01.
62 total (US= 19 devices  and 32 kits; International = 11 devices)
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood product, in which quality control and distribution of product that did not meet specifications, was distributed.
AL, MO and UT  Canada, Australia, Netherlands, and Egypt
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Part of the number on the tray lid differ from the part number on the base.
Part Number 46-1610 // Lot Number 709730  Part Number 46-1610 // Lot Number 709740  Part Number 46-1620 // Lot Number 709710  Part Number 46-1620 // Lot Number 709720
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System.  For ophthalmic use.
Packaging error.   20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a  20GA package.
Part Number NGP0025 Lot CA06182 (72 units)  Part Number NGP0020 Lot CA06180 (288 units)
Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Zimbabwe
US Distribution to the states of : FL and CA.  No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
Decorated (iced) holiday cookies sold in the shape of eggs. These cookies were sold in the self service cookie displays.  Individual cookies are 1.3 oz.. each.    Cookie labels identify the cookies as:  Sugared Purple Egg Cookies: Sugar Pink Bunny Cookie; Sugared Yellow Chick Cookie; Iced Easter Egg Cookie;    Ingredients: Iced  Sugared egg, bunny and chick cookies for original, uncorrected shelf tags.    Contains Wheat:  Ingredients: Unbleached Unbromated Wheat flour (wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), Cane Sugar, Palm Fruit Oil, Vanilla, Water, Baking Soda, Salt. Natural coloring.    Napa store Iced Easter Egg Cookie - uncorrected:  Contains: Eggs, Milk, Soy, Tree nuts  Ingredients: Rice Flour, Sugar, Unsalted Butter, Eggs, Milk, Tapioca Starch, Potato Starch, Vanilla Extract, Pure Almond Extract, Baking Powder, cornstarch, bicarbonate of soda, monocalcium Phosphate_ Kosher salt, Xanthan Gum, Sucrose Maltodextrin, Natural Red Food Color (plan extractives) Natural Green Food Color (alfalfa, Natural Yellow Food Color (plant extracts).
No codes - sold in self service bin - holiday shapes  Cookies sold on or prior to April 14, 2017.
Decorated (sugared) holiday cookies sold in the shape of purple eggs, pink bunnies or yellow chicks. These cookies were sold in the self service cookie display.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Product was shipped to the following states: CA, FL, GA, IN, MI, NJ, OH, RI & PA.
Moondance desserts gluten free Mexican Wedding Cookie 8 oz (227g)  UPC 7 36211 68076 1
Moondance desserts gluten free Chocolate Chip Cookie Bar 12 oz (340g)  UPC 36211 68096 9
Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.
Arietta 70 Ultrasound System    Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Worldwide Distribution - US Distribution and to the countries of Finland and China.
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
ARIES System UDI:  00840487101537 and ARIES M1 System UDI:  00840487100080
Desoximetasone Ointment USP, 0.25%, 15 g tubes,  Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310    NDC 52565-030-15
White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs.    Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Lint present on sterile Operating Room Towels.
Material Number: MSPT524, Lot #229445, Exp. Date: 10/12/2021.
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs).    Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Material Number: AVID260, Lot #231253, Exp. Date: 10/31/2021 (48 pk) and Material Number: MSPT504, Lot #229259, Exp. Date: 10/12/2021 (20 pk).
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit;  Model PCE-5012; Qty: 10 each.    Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory  support.
Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
VORTRAN Automatic Resuscitator, VARPlus;  Model PTE-5002; Qty: 10 each    Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory  support.
Worldwide Distribution- US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran (Islamic Republic Of), Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, Monaco, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province Of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
Over time, low-frequency vibrations can cause the pins within the female connectors on  the Motor Controller to Data Acquisition Board ribbon cable to become partially  displaced causing momentary high resistance that prevents or restricts data travelling  through the cable during the high resistance event.
Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico
SoftPort Easy-Load Lens Delivery System  Model: EZ-28V  Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.
Complaints concerning kinked haptics that were occurring during lens delivery.
Lot Number:  H671901 Expiration Date: Dec-17,   Lot Number:  H672001 Expiration Date: Nov-17,  Lot Number:  H672602 Expiration Date: Dec-17,  Lot Number:  H674001 Expiration Date: Dec-17,  Lot Number:  H674401 Expiration Date: Nov-17,  Lot Number:  H674801 Expiration Date: Dec-17,  Lot Number:  H675401 Expiration Date: Dec-17,  Lot Number:  H740301 Expiration Date: Dec-17, and   Lot Number:  H743201 Expiration Date: Feb-18.
AL, CA, FL, IA, IL, LA, MA, MD, MI, MN, NC, ND, NJ, NY, PA, SC, TX, VA, VT, and WI
Kemps YO2 Frozen Yogurt Salty Caramel Cookie Crunch, One Pint, UPC 41483-04123
Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.
Kemps Sweet Me Creamery Vanilla Bean, One Pint, UPC 41483-04142
Kemps Sweet Me Creamery Strawberry Rhubarb Cobbler, One Pint, UPC 41483-04145
Kemps Sweet Me Creamery Salted Caramel Brownie, One Pint, UPC 41483-04141
Kemps YO2 Frozen Yogurt Chocolate Peanut Butter Fudge, One Pint, UPC 41483-04126
Kemps YO2 Frozen Yogurt Cold Brewed Coffee, One Pint, UPC 41483-04122
Kemps YO2 Frozen Yogurt Raspberry Cheesecake, One Pint, UPC 41483-04127
Kemps Sweet Me Creamery Maple Toffee Blondie, One Pint, UPC 41483-04146
Kemps Sweet Me Creamery Creamy Dark Chocolate Mint, One Pint, UPC 41483-04143
Kemps Sweet Me Creamery Expresso Mocha, One Pint, UPC 41483-04140
Kemps YO2 Frozen Yogurt Mudslide, One Pint, UPC 41483-04121
Kemps YO2 Frozen Yogurt Very Vanilla, One Pint, UPC 41483-04124
Kemps Sweet Me Creamery Chocolate Peanut Butter Pretzel, One Pint, UPC 41483-04144
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France
WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO,    Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device.
RALEY'S MUESLI RED BERRY CRUNCH CEREAL;  12 oz. box - foil bag inside paper box.  UPC: 46567-02264;product Distributed by Raley's, West Sacramento, CA;Product of Switzerland
Internal label review found that coconut was not listed in the allergen declaration
RALEY'S MUESLI ALMOND CRUNCH MUESLI CEREAL;  12 oz. box - foil bag inside paper box.  UPC: 46567-02263; Product Distributed by Raley's, West Sacramento, CA; Product of Switzerland
RALEY'S MUESLI CHOCOLATE CURLCRUNCH CEREAL;  12 oz. box - foil bag inside paper box.  UPC: 46567-02266;Product Distributed by Raley's, West Sacramento, CA;Product of Switzerland
Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
Brennen Skin Graft Mesher.    Surgical instrument designed to expand skin grafts'
Please note bownie is how this word appears on the label.    UPC 6 96859 21161 4    The product is packed in paper pint containers with paper and plastic lid.  Product is shrink wrapped six per flat (not in a cardboard case) and not packed in a master carton.  Distributed as shrink wrapped, six pints per flat.
Full Tilt Ice Cream is recalling pint size ice cream due to undeclared allergen, wheat.  Flour is listed in the ingredient statement, however wheat is not declared.
116 16  through 114 17   Julian date      Calendar year
INTENSIA Models:  VR 124, DR 154, CRT-D 174    Product Usage:  OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
OVATIO Models:  VR 6250, DR 6550, CRT 6750.     Product Usage:  OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
PARADYM Models:  VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770    Product Usage:  OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
Product Code: ICV1199, ICV1200, ICV1179, TDF011U, TDF010U, TDF012U
Worldwide Distribution -  US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries  of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria.    VA/DOD: None
NexGen Offset Stem Extension, sizes 14mm and 17mm      For use in total arthroplasty.
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
I.Q.F Chopped Spinach, Del Mar Foods Product Corp;  35 lb.  Net Weight.  brown case fiber with polyliner    Del Mar Food Products; Watsonville, CA 95077
Firm was notified by customer of a positive Listeria Monocytogenes result during routine testing upon receipt of IQF frozen chopped spinach supplied by Del Mar Food Products.
Frozen Spinach Code 1231V 160422;     A  black stencil with:     1231V  160422
Distributed in Maryland, Massachusetts, New Jersey, New York, Pennsylvania and Virginia
1,016 cases (12/28 oz. packages per case)
Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
Mobius3D    Product Usage:  Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0) and the prior version (1.4.2), where none should have been expected.
Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
Protein Bar 14 bars/box, Net Wt. 19.74oz (560g)    Each shipping carton contains 12 boxes
Herbalife is recalling Protein Bar-Peanut Butter because it may contain a trace amount of fish gelatin.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Platelet products, for which product quality control testing was not performed, were distributed.
Wegmans Wegmans Family Pack Potato Salad, Net Wt. 48 OZ; Ingredients: Pasta Shells***Water, Cucumbers, Feta Cheese...ect;  Allergens: Contains Milk and Wheat; Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603;    Sell By: 5/7/17   3379-4;  UPC: 7789024678
Wegman's Potato Salad, Net Wt. 48 oz is being recalled for undeclared egg as the containers were labeled with a nutritional and ingredient statement from a different product.
Blood product, in which donor suitability was not adequately determined, was distributed.
Blood products, in which donor suitability was not adequately determined, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
US and foreign countries: United Arab Emirates, Colombia, and Canada
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Baxalta (Formerly Baxter Healthcare Corp)
Vonvendi, with a package insert error, was distributed.
Normed General Instruments  503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft  The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
the devices used a different raw material to produce two countersink products which has higher  hardness and higher carbon content resulting in device damage.
Plateletpheresis product, lacking assurance of proper leukoreduction, was distributed.