BEUDAMED
    FDA Recall Terminated

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

    Recall: Z-1340-2018 · Initiated January 10, 2018

    Recall

    Recall Number
    Z-1340-2018
    Event Number
    79541
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 10, 2018
    Terminated
    April 11, 2019
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

    Reason

    Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

    Action

    On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.

    Distribution

    Distribution US Nationwide, Canada, India, and Colombia.

    Quantity

    180