Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports
Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reports of air or gas embolism, which constitutes a significant injury report, meeting the criteria for a Severe (4) rating.
Plain-English summary
Ethicon, Inc. and Omrix Biopharmaceuticals are recalling EVICEL Fibrin Sealant (Human) pressure regulators. The recall involves 4,800 pressure regulators distributed worldwide, including 1,500 units distributed within the United States. The product is distributed by Ethicon, Inc. and manufactured by Omrix Biopharmaceuticals Ltd.
The recall was initiated after the companies received reports of air or gas embolism occurring in association with the use of spray devices employing a pressure regulator to administer EVICEL. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface.
The field correction initiated is to provide the recommended usage guidelines. The recall includes all lots and product codes for EVICEL and Omrix pressure regulators.
The recalled product
- Product
- EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The…
- Manufacturer
- Ethicon, Inc.
- Hazard
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 (1)
- To include all lots and product codes for EVICEL and Omrix pressure regulators.
Distribution
Distributed nationwide across the United States.
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