Recall Z-2792-2011 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Abbott Vascular
Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
| Date | Jul 12, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 389 units total |
| Distribution | Nationwide distribution, and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 Guidant Corp., Jun 9, 1999 |