BEUDAMED
    FDA Recall Terminated

    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding

    Recall: Z-2622-2017 · Initiated May 9, 2017

    Recall

    Recall Number
    Z-2622-2017
    Event Number
    77300
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 9, 2017
    Terminated
    February 13, 2019
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding

    Reason

    Cotton tip of the device may disengage due to insufficient adhesive

    Action

    Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000.

    Distribution

    Nationwide Distribution

    Quantity

    194,851