BEUDAMED
    FDA Recall Terminated

    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

    Recall: Z-1855-2016 · Initiated March 3, 2016

    Recall

    Recall Number
    Z-1855-2016
    Event Number
    73427
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 3, 2016
    Posted
    May 31, 2016
    Terminated
    June 15, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

    Reason

    Compromised sterility due to breach of barrier

    Action

    Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878

    Distribution

    Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

    Quantity

    350550