BEUDAMED
    FDA Enforcement Class II Terminated

    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

    Recall: Z-1409-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1409-2017
    Event ID
    76327
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 23, 2017
    Classification Date
    March 4, 2017
    Termination Date
    August 7, 2019
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

    Reason

    Sterility compromised due to breach in sterile barrier

    Code Info

    Lot Numbers: 1410577-4 to 1605778

    Distribution

    Nationwide

    Quantity

    42,750 units