Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect
Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.
What this means for you
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 I, which is typically a low-risk defect unlikely to cause adverse health consequences. The hazard is a potential breach of sterile packaging, which is a theoretical risk without reported injuries.
Plain-English summary
Ethicon, Inc. is recalling 45,200 units of SURGIFLO Hemostatic Matrix Kit and SURGIFLO Hemostatic Matrix Kit with Thrombin. The recall is due to a defect in the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
The affected lots are 239091, 238783, 238635, 237498, 237119, and 235488, with expiration dates ranging from January 2013 to September 2013. The product was distributed nationwide in the United States as well as in Russia, China, and the European Union.
SURGIFLO Hemostatic Matrix is a topical absorbable hemostat used in surgical procedures as an adjunct to hemostasis when conventional methods are ineffective. Users should stop using the affected kits and contact Ethicon for further instructions.
The recalled product
- Product
- ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applyi
- Manufacturer
- Ethicon, Inc.
- Affected units
- 45,200
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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