BEUDAMED
    FDA Recall Terminated

    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.

    Recall: Z-2080-2014 · Initiated June 20, 2014

    Recall

    Recall Number
    Z-2080-2014
    Event Number
    68624
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    LJH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2014
    Posted
    July 19, 2014
    Terminated
    October 15, 2014
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.

    Reason

    Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.

    Action

    Stryker sent an Urgent Device Removal letter via certified mail on June 20, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused product, inform individuals within their organization who need to aware of the device removal. Customers with questions were instructed to call 1-800-624-4422. For questions regarding this recall call 408-754-2664.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.

    Quantity

    496 boxes (6 tips per box)