BEUDAMED
    FDA Recall Terminated

    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

    Recall: Z-1408-2017 · Initiated January 23, 2017

    Recall

    Recall Number
    Z-1408-2017
    Event Number
    76327
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    MMP
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 23, 2017
    Terminated
    August 7, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 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

    Action

    Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department.

    Distribution

    Nationwide

    Quantity

    1,111,600 units