Events

Recall of EVARREST

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71372
  • Event Risk Class
    Class 2
  • Event Number
    Z-1996-2016
  • Event Initiated Date
    2016-04-11
  • Event Date Posted
    2016-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145857
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gauze/sponge, internal, with drug/biologic, animal source material - Product Code GEL
  • 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.

Device

EVARREST
  • Model / Serial
    Product Code #EVT5024, Lot #U01F012A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA