BEUDAMED
    FDA Recall Terminated

    Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.

    Recall: Z-2335-2008 · Initiated July 7, 2008

    Recall

    Recall Number
    Z-2335-2008
    Event Number
    48971
    Firm
    Integra Pain Management
    FEI Number
    1000138491
    Product Code
    LZC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 7, 2008
    Posted
    September 20, 2008
    Terminated
    October 29, 2008
    Address
    3395 W 1820 S, Salt Lake City, UT, 84104-4921

    Description

    Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.

    Reason

    Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.

    Action

    On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210.

    Distribution

    AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.

    Quantity

    140 boxes