BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1338-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1338-2018
    Event ID
    79541
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    January 10, 2018
    Classification Date
    April 10, 2018
    Termination Date
    April 11, 2019
    Address
    Us Highway 22 West, Somerville, NJ, 08876, United States

    Description

    PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-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.

    Code Info

    Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459

    Distribution

    Distribution US Nationwide, Canada, India, and Colombia.

    Quantity

    7020