BEUDAMED
    FDA Recall Terminated

    Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791

    Recall: Z-1635-2008 · Initiated March 18, 2008

    Recall

    Recall Number
    Z-1635-2008
    Event Number
    47373
    Firm
    Integra Pain Management
    FEI Number
    1000138491
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 18, 2008
    Posted
    August 14, 2008
    Terminated
    November 5, 2008
    Address
    3395 W 1820 S, Salt Lake City, UT, 84104-4921

    Description

    Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791

    Reason

    Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.

    Action

    Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.

    Distribution

    CO

    Quantity

    500 kits