BEUDAMED
    FDA Recall 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 · Initiated June 13, 2014

    Recall

    Recall Number
    Z-2024-2014
    Event Number
    68607
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    GAR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 13, 2014
    Posted
    July 9, 2014
    Terminated
    October 7, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    A correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.

    Distribution

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

    Quantity

    11