BEUDAMED
    FDA Recall Terminated

    All Med Medical 22ga x 1.5" Winged Administration Set w/Y Site Model # M2215Y Reorder # 50-2242

    Recall: Z-2532-2010 · Initiated August 30, 2010

    Recall

    Recall Number
    Z-2532-2010
    Event Number
    56548
    Firm
    Multi-Med, Inc.
    FEI Number
    1221765
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 30, 2010
    Posted
    September 29, 2010
    Terminated
    January 31, 2013
    Address
    26 Victoria Court, Keene, NH, 03431

    Description

    All Med Medical 22ga x 1.5" Winged Administration Set w/Y Site Model # M2215Y Reorder # 50-2242

    Reason

    Huber needles may core and result in port leakage or emboli being flushed our of the port.

    Action

    Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.

    Distribution

    Worldwide Distribution -- USA and Mexico.

    Quantity

    1,620 units