BEUDAMED
    FDA Recall Terminated

    Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.

    Recall: Z-0652-2009 · Initiated October 1, 2008

    Recall

    Recall Number
    Z-0652-2009
    Event Number
    50141
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 1, 2008
    Posted
    January 21, 2009
    Terminated
    December 16, 2010
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.

    Reason

    Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.

    Action

    Stryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.

    Distribution

    Nationwide.

    Quantity

    1440 devices