BEUDAMED
    FDA Enforcement Class II Terminated

    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures

    Recall: Z-2024-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2024-2014
    Event ID
    68607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    June 13, 2014
    Classification Date
    July 9, 2014
    Termination Date
    October 7, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures

    Reason

    Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.

    Code Info

    Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055

    Distribution

    Distributed in the states of IL, NY, GA, and RI.

    Quantity

    11