BEUDAMED
    FDA Recall Terminated

    Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618

    Recall: Z-0802-03 · Initiated April 10, 2003

    Recall

    Recall Number
    Z-0802-03
    Event Number
    25958
    Firm
    Hu-Friedy Mfg Co, Inc.
    FEI Number
    1416605
    Product Code
    GAB--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 10, 2003
    Posted
    May 9, 2003
    Terminated
    March 24, 2004
    Address
    3232 N Rockwell, Chicago, IL, 60618-5935

    Description

    Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618

    Reason

    The suture needles were mislabeled with the wrong size.

    Action

    Hu-Friedy sent recall letters dated 4/10/03 to their accounts on the same date, informing them that the incorrect size needle was packaged as SN4 suture needles, and requesting them to quarantine all warehouse stocks of SN4 suture needles for return to Hu-Friedy for replacement and to notify their sub-accounts.

    Distribution

    Michigan, Massachusetts, California, Pennsylvania, Texas, Washington, New York, Wisconsin, Iowa, Indiana, Tennessee, New Jersey, Louisiana, South Carolina, Florida, and internationally to Canada, Australia and New Zealand.

    Quantity

    200 vials