ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- March 30, 2012
- Posted
- April 18, 2012
- Terminated
- October 25, 2012
- Recall Number
- Z-1437-2012
- Quantity
- 4,070
- Firm Location
- Sellersville, PA
Reason for Recall
Lack of assurance of sterility
Distribution
Nationwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV and Washington, D.C.
Lot / Code Info
Product code 1000-46-06, lot # 16EK007, exp 10/2012; and 16EK0193, exp 10/2012
Root Cause
Material/Component Contamination
Action Taken
Teva Pharmaceuticals USA sent an "URGENT MEDICAL DEVICE RECALL-RETAIL LEVEL" letter dated March 30, 2012. The letter identifies the problem, product, and actions to be taken by the customers. The letter instructs customers to check their inventory and to discontinue distribution of the affected product. A Stock Response Form was enclosed for customers to complete and return via fax to 817-868-5362. Contact Teva Customer Services at 800-545-8800 for questions regarding this notice.