Z-1996-2016Class II

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

Name: Z-1996-2016 EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with...
Creator: Ethicon, Inc.
Published: 2016-04-11
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2016-04-11 / Terminated / root cause: labeling and UDI

FDA source

Ethicon, Inc. began a recall of EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis... on 2016-04-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1996-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-11
Posted: 2016-06-15
Terminated: 2017-08-02
Recalling firm: Ethicon, Inc
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.
Product code: GEL
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).
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Product Code #EVT5024, Lot #U01F012A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1996-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15

Product code GEL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)