EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual com

FDA device recall Z-1996-2016 · posted 2016-06-15 · Terminated

Recall details

Recalling firm

Ethicon, Inc.

Reason for recall

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 taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

GEL

Quantity affected

228 units

Distribution

Nationwide Distribution

Date initiated

2016-04-11

Date posted

2016-06-15

Date terminated

2017-08-02

Location

Somerville, NJ