Reported Jun 22, 2016 · Terminated
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · US Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- EVARREST Fibrin Sealant Patch
- Manufactured byOmrix 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
- Lot codes and dates
Product Code #EVT5024Lot #U01F012A
- Amount recalled
- 228 units
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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