BEUDAMED
    FDA Enforcement Class II 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 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0533-2014
    Event ID
    66885
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    October 28, 2013
    Classification Date
    December 17, 2013
    Termination Date
    January 29, 2014
    Address
    3498 West 2400 South #1050, N/A, Salt Lake City, UT, 84119, United States

    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.

    Code Info

    Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,

    Distribution

    USA Nationwide Distribution and one foreign consignee in Mursalat.

    Quantity

    359,250