BEUDAMED
    FDA Recall Terminated

    StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138

    Recall: Z-0279-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0279-06
    Event Number
    34112
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    December 14, 2005
    Terminated
    November 2, 2006
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138

    Reason

    Devices for which sterility may be compromised as evidenced by a crack in the package.

    Action

    On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    The product was distributed nationally to 1321 consignees and internationally to 18 consignees.

    Quantity

    48405 boxes, 6 units per box