BEUDAMED
    FDA Recall Terminated

    Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.

    Recall: Z-0670-06 · Initiated February 3, 2006

    Recall

    Recall Number
    Z-0670-06
    Event Number
    34545
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 3, 2006
    Posted
    March 21, 2006
    Terminated
    June 4, 2007
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.

    Reason

    The catheter tubing included in the kit may break during removal.

    Action

    Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.

    Distribution

    Nationwide, Australia and Canada.