BEUDAMED
    FDA Recall Terminated

    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

    Recall: Z-0533-2014 · Initiated October 28, 2013

    Recall

    Recall Number
    Z-0533-2014
    Event Number
    66885
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    FEI Number
    1000138491
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 28, 2013
    Posted
    December 17, 2013
    Terminated
    January 29, 2014
    Address
    3498 West 2400 South, # 1050, Salt Lake City, UT, 84119

    Description

    Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

    Reason

    Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

    Action

    BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762.

    Distribution

    USA Nationwide Distribution and one foreign consignee in Mursalat.

    Quantity

    359,250