BEUDAMED
    FDA Recall Terminated

    Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.

    Recall: Z-2575-2011 · Initiated May 19, 2011

    Recall

    Recall Number
    Z-2575-2011
    Event Number
    58995
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2011
    Posted
    June 22, 2011
    Terminated
    August 1, 2011
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.

    Reason

    Kits contain protective wipes that may be contaminated with Bacillus cereus.

    Action

    Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210.

    Distribution

    UT

    Quantity

    520 kits