FDAApril 11, 2016device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
ethicon
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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