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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging."
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…
- 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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