BEUDAMED
    FDA Enforcement Class II Completed

    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L

    Recall: Z-0748-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0748-2021
    Event ID
    86886
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 6, 2021
    Initiation Date
    November 23, 2020
    Classification Date
    December 29, 2020
    Address
    15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States

    Description

    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L

    Reason

    May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

    Code Info

    Lot Numbers: P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY,P0D1444MY, P0E1211MY, P0F0606MY. UDI: 10884521043152, 20884521043159

    Distribution

    Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Viet Nam

    Quantity

    5316 units US; 1209 units OUS