Recall Z-1996-2016— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2016-04-11, terminated 2017-08-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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)..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-11
- Terminated
- 2017-08-02
- Firm location
- Somerville, NJ, United States
Product description
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.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.