Device 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.
Z-1996-2016
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 71372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 228 units
- Official record key
device-enforcement:Z-1996-2016
Official wording
Reason: 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).
Code information: Product Code #EVT5024, Lot #U01F012A
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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).