BEUDAMED
    FDA Recall Terminated

    Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238

    Recall: Z-0858-05 · Initiated May 5, 2005

    Recall

    Recall Number
    Z-0858-05
    Event Number
    32076
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2005
    Posted
    June 1, 2005
    Terminated
    May 8, 2012
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238

    Reason

    Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"

    Action

    Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005.

    Distribution

    Nationwide

    Quantity

    159 cases (400 per case) =63,600 each.