BEUDAMED
    FDA Recall Terminated

    Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025.

    Recall: Z-1826-2009 · Initiated May 14, 2009

    Recall

    Recall Number
    Z-1826-2009
    Event Number
    52163
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2009
    Posted
    September 4, 2009
    Terminated
    January 20, 2010
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025.

    Reason

    Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

    Action

    Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.

    Distribution

    Nationwide and Canada.

    Quantity

    28,755 of all pumps