BEUDAMED
    FDA Enforcement Class II Terminated

    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

    Recall: Z-0733-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0733-2017
    Event ID
    75793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 28, 2016
    Classification Date
    December 12, 2016
    Termination Date
    September 6, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

    Reason

    Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.

    Code Info

    catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835 Exp date 9/30/2018

    Distribution

    AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI

    Quantity

    99 units