BEUDAMED
    FDA Recall Terminated

    ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

    Recall: Z-1841-2019 · Initiated April 19, 2019

    Recall

    Recall Number
    Z-1841-2019
    Event Number
    82909
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAQ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 19, 2019
    Terminated
    February 5, 2021
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

    Reason

    Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

    Action

    Ethicon notified primary and secondary US consignees by telephone on 4/19/19 and follow-up letter dated April 24, 2019 stating reason for recall, health risk and action to take: examine inventory, remove product for return. Complete the Business Reply Form (BRF) to Stericycle at 1-844-721-3045 or [email protected]. Questions regarding this action or to report any customer complaints, please contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.

    Distribution

    Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada

    Quantity

    1296 eaches