Ethicon Recalls EVARREST Fibrin Sealant Patch Due to Labeling Error
Ethicon is recalling 228 units of EVARREST Fibrin Sealant Patch because the expiration date field on the foil pouch labels contains the text '0-bad' instead of the valid date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling error where the expiration date is illegible or incorrect, which is a minor labeling issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ethicon, Inc. is recalling 228 units of EVARREST Fibrin Sealant Patch, manufactured by Omrix Biopharmaceuticals, Ltd. The product is 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 standard surgical methods are ineffective or impractical.
The recall was initiated 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 of 2016-12-28. The affected units are identified by Product Code #EVT5024 and Lot #U01F012A.
The product was distributed nationwide. Healthcare providers and facilities that have received this product should stop using it and contact Ethicon for further instructions.
The recalled product
- 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…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 228
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code #EVT5024
- Lot #U01F012A
Distribution
Distributed nationwide across the United States.
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