Recall Z-1437-2012 ยท KDL Set, Perfusion, Kidney, Disposable
Teva Pharmaceuticals USA, Inc.
ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
| Date | Apr 18, 2012 (initiated Mar 30, 2012) |
| Status | Terminated |
| Reason | Lack of assurance of sterility |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 4,070 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944866 | VIASPAN (BELZER UW - CSS) The Dupont Merck Pharmaceutical Co., Apr 22, 1996 |