BEUDAMED
    FDA Recall Terminated

    Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.

    Recall: Z-2792-2011 · Initiated January 7, 2011

    Recall

    Recall Number
    Z-2792-2011
    Event Number
    58979
    Firm
    Abbott Vascular
    FEI Number
    2024168
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 7, 2011
    Posted
    July 12, 2011
    Terminated
    June 26, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.

    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.

    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

    Distribution

    Nationwide distribution, and Ireland.

    Quantity

    389 units total