BEUDAMED
    FDA Recall Terminated

    Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301

    Recall: Z-1177-06 · Initiated June 2, 2006

    Recall

    Recall Number
    Z-1177-06
    Event Number
    35610
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HET
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 2, 2006
    Posted
    June 27, 2006
    Terminated
    November 20, 2006
    Address
    5900 Optical Ct, San Jose, CA, 95138

    Description

    Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301

    Reason

    Device for which sterility may be compromised as evidenced by a loss of package integrity.

    Action

    On 6/2/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Nationwide