Ethicon Surgiflo Hemostatic Matrix Kit Recalled for Potential Non-Sterility
Ethicon is recalling Surgiflo Hemostatic Matrix Kits with Thrombin because an undetected air leak during manufacturing may have compromised the sterility of the thrombin component.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used in surgical procedures. No illnesses or injuries are reported in the source text, placing the risk at the 'High' level per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling the Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip. The recall involves 27,396 kits distributed nationwide in the United States. The product is indicated for surgical procedures, excluding ophthalmic procedures, to control capillary, venous, and arteriolar bleeding when conventional methods are ineffective or impractical.
The recall is being issued because the lyophilized thrombin component of the kit has the potential to be non-sterile. This risk is attributed to an undetected air leak that occurred during the manufacturing process. The affected lots include specific product codes and expiration dates ranging from June 2012 to March 2013.
Healthcare providers and facilities that have received these kits should stop using them immediately. Ethicon, Inc. is the recalling firm and is responsible for managing the recall. Users should contact Ethicon for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 27,396
Distribution
Distributed nationwide across the United States.
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