BEUDAMED
    FDA Recall Terminated

    CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.

    Recall: Z-1417-2009 · Initiated April 6, 2009

    Recall

    Recall Number
    Z-1417-2009
    Event Number
    51962
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    GDM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 6, 2009
    Posted
    May 26, 2009
    Terminated
    May 27, 2009
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.

    Reason

    Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.

    Action

    The distributor was notified on Monday, April 6, 2009 via telephone by the QA Manager and a return authorization was issued. A notification letter dated April 13, 2009 was issued via certified mail to the affected customers. The letter described the affected product, reason for recall and actions for customers. Customers were also instructed to conduct recall to user level. For questions or additional information, contact Remington Medical, Inc. by calling 800-989-0057, extension 123.

    Distribution

    Nationwide Distribution -- KY and NC.

    Quantity

    60 units