FDA Enforcement
Class II
Terminated
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.
Recall: Z-1996-2016
·
Reported June 22, 2016
Enforcement
- Recall Number
- Z-1996-2016
- Event ID
- 71372
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ethicon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 22, 2016
- Initiation Date
- April 11, 2016
- Classification Date
- June 15, 2016
- Termination Date
- August 2, 2017
- Address
- US Highway 22 West, Somerville, NJ, 08876, United States
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
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 Info
Product Code #EVT5024, Lot #U01F012A
Distribution
Nationwide Distribution
Quantity
228 units