ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Di
FDA device recall Z-1437-2012 · posted 2012-04-18 · Terminated
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Reason for recall
- Lack of assurance of sterility
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- KDL
- Quantity affected
- 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
- Date initiated
- 2012-03-30
- Date posted
- 2012-04-18
- Date terminated
- 2012-10-25
- Location
- Sellersville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIASPAN (BELZER UW - CSS) (K944866) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 |