BEUDAMED
    FDA Enforcement Class II Terminated

    regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    Recall: Z-0039-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0039-2016
    Event ID
    71904
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Resource Optimization & Innovation Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 14, 2015
    Initiation Date
    April 22, 2015
    Classification Date
    October 7, 2015
    Termination Date
    March 28, 2017
    Address
    2909 N Neergard Ave, N/A, Springfield, MO, 65803, United States

    Description

    regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    Reason

    The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

    Code Info

    Lot numbers 14886, 18136, 19831, 22808, and 23940.

    Distribution

    Distribution was made to LA, MS, and TX.

    Quantity

    400 kits