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U.S. Department of Health and Human Services

Class 2 Device Recall EVARREST

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  Class 2 Device Recall EVARREST see related information
Date Initiated by Firm April 11, 2016
Date Posted June 15, 2016
Recall Status1 Terminated 3 on August 02, 2017
Recall Number Z-1996-2016
Recall Event ID 71372
Product Classification Gauze/sponge, internal, with drug/biologic, animal source material - Product Code GEL
Product 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.
Code Information Product Code #EVT5024, Lot #U01F012A
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Mr. Hal Delgado
954-441-3090
Manufacturer 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).
FDA Determined
Cause 2		 Error in labeling
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.
Quantity in Commerce 228 units
Distribution Nationwide Distribution
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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