BEUDAMED
    FDA Enforcement Class II Terminated

    PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. 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 anesthetics.

    Recall: Z-2868-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2868-2016
    Event ID
    75029
    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
    E-Mail
    Report Date
    September 28, 2016
    Initiation Date
    August 24, 2016
    Classification Date
    September 21, 2016
    Termination Date
    December 19, 2016
    Address
    3498 W 2400 S Ste 1050, Salt Lake City, UT, 84119-1135, United States

    Description

    PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. 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 anesthetics.

    Reason

    Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.

    Code Info

    Lot Number affected: W1503532

    Distribution

    Distributed to CA.

    Quantity

    320 packages