BEUDAMED
    FDA Recall Terminated

    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.

    Recall: Z-1996-2016 · Initiated April 11, 2016

    Recall

    Recall Number
    Z-1996-2016
    Event Number
    71372
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    GEL
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 11, 2016
    Posted
    June 15, 2016
    Terminated
    August 2, 2017
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.

    Reason

    Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).

    Action

    Ethicon sent an "Urgent: Product Recall (Removal)," dated April 14, 2016 via UPS next day mail to their affected customers. The letter identified the affected product and the reason for the recall. The letter also states that product from the affected lot is still within the expiration date, and health care practitioners, who have treated patients with the product should continue to follow patients in the usual manner. Users are to examine their inventory and quarantine the affected product. The affected product should be returned per the instructions outlined in the letter. Ethicon will provide replacement product upon receipt. Customers are to complete and return the Business Reply Form. If customers need assistance returning the product, they can contact Stericycle at 1-866-761-9472. If there are questions regarding the replacement product, customers can contact Ethicon Customer Support Center at 1-877-ETHICON.

    Distribution

    Nationwide Distribution

    Quantity

    228 units