BEUDAMED
    FDA Recall Terminated

    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia

    Recall: Z-1219-2007 · Initiated July 20, 2007

    Recall

    Recall Number
    Z-1219-2007
    Event Number
    39362
    Firm
    Molnlycke Health Care, Inc
    FEI Number
    1629080
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 20, 2007
    Posted
    September 8, 2007
    Terminated
    March 17, 2010
    Address
    5550 Peachtree Pkwy, Ste 500, Norcross, GA, 30092-2555

    Description

    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia

    Reason

    Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.

    Action

    Consignees were notified by registered mail on 07/23/2007. The notice contained a Recall Response Form to confirm receipt of the notice and to verify if the product is still in inventory. The notice instructed to consignee to inspect their inventory for Biogel Skinsense Polyisoprene Surgical Gove, lot #07B026, Size 8. If this lot and size are in their inventory, they were instructed to discontinue use, quarantine the product and return the product to Molnlycke Healthcare.

    Distribution

    Nationwide including states of AZ, CA, CT, KY, MD, MN, MO, TN, and WI

    Quantity

    6,000 pair