Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
- Company
- Abbott Vascular
- Recall Initiated
- January 7, 2011
- Posted
- July 12, 2011
- Terminated
- June 26, 2012
- Recall Number
- Z-2792-2011
- Quantity
- 389 units total
- Firm Location
- Temecula, CA
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.
Distribution
Nationwide distribution, and Ireland.
Lot / Code Info
Lot Number: 0121191
Root 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