BEUDAMED
    FDA Recall Terminated

    Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    Recall: Z-0722-2010 · Initiated November 12, 2009

    Recall

    Recall Number
    Z-0722-2010
    Event Number
    54149
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    cac
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 12, 2009
    Posted
    January 29, 2010
    Terminated
    October 25, 2010
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    Reason

    The product may not be sterile due to package not being intact.

    Action

    Stryker issued a "Medical Device Recall Notification" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm. For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808.

    Distribution

    Worldwide Distribution.

    Quantity

    79,617