Recall Z-2792-2011
Abbott Vascular · initiated January 7, 2011
Product
Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
Codes / lots: Lot Number: 0121191
Reason for recall
Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
FDA-determined cause: Process control
Action taken
Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product
Details
- Recall number
- Z-2792-2011
- Initiated
- January 7, 2011
- Posted by FDA
- July 12, 2011
- Terminated
- June 26, 2012
- Product code
- DTL – Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Quantity
- 389 units total
- Distribution
- Nationwide distribution, and Ireland.
- Recalling firm
- Abbott Vascular, Temecula, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2791-2011 | Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac…Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO)… | 01/07/2011Terminated |
| Z-2793-2011 | Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100.…Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO)… | 01/07/2011Terminated |