BEUDAMED
    FDA Recall Terminated

    21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    Recall: Z-2363-2010 · Initiated February 1, 2010

    Recall

    Recall Number
    Z-2363-2010
    Event Number
    54625
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    GXZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 1, 2010
    Posted
    September 3, 2010
    Terminated
    March 28, 2011
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    Reason

    Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

    Action

    Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354

    Distribution

    Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.

    Quantity

    18,826 all products.