BEUDAMED
    FDA Enforcement Class II Terminated

    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.

    Recall: Z-0185-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0185-2016
    Event ID
    72052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Resource Optimization & Innovation Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 4, 2015
    Initiation Date
    August 25, 2015
    Classification Date
    October 29, 2015
    Termination Date
    April 6, 2017
    Address
    2909 N Neergard Ave, N/A, Springfield, MO, 65803, United States

    Description

    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.

    Reason

    Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

    Code Info

    19215, 19570, 20849, 22557, 23871, 25469, and 27185

    Distribution

    Distributed in Texas and Louisiana.

    Quantity

    80 kits