BEUDAMED
    FDA Recall Terminated

    22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.

    Recall: Z-1888-2010 · Initiated May 26, 2010

    Recall

    Recall Number
    Z-1888-2010
    Event Number
    55824
    Firm
    Multi-Med, Inc.
    FEI Number
    1221765
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    May 26, 2010
    Posted
    July 2, 2010
    Terminated
    May 23, 2017
    Address
    26 Victoria Ct, Keene, NH, 03431-4218

    Description

    22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.

    Reason

    FDA sample determined the needles to be coring.

    Action

    The firm, Multi Med, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 26, 2010 to their sole consignee Navilyst Medical, Inc., via email and overnight courier with signature notification. The letter describes the product, problem and action to be taken by customer. The customers was instructed to immediately examine their inventory and quarantine product subject to recall, if the product was distributed to others customers, identify and notify them at once and include recall notification letter,. Recall has been initiated due to FDAs sample analysis that these needles may core implanted port septums. If you have any questions, call me, Sue Starkey, at 603-357-8733 or via email at [email protected].

    Distribution

    Worldwide distribution

    Quantity

    5169