Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall
Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the 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 the Ethicon Surgiflo Hemostatic Matrix Kit Plus FlexTip with Thrombin. The recall involves 28,276 units distributed nationwide in the United States and in Russia, China, and the European Union. The affected lots are 239346 (expiring January 2013) and 239411 (expiring June 2013).
The recall is due to an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. This defect may compromise the integrity of the sterile barrier for the hemostatic matrix and thrombin components.
Healthcare providers and facilities should stop using the affected products and contact Ethicon for instructions on return or replacement. The product is indicated for surgical procedures for hemostasis when conventional procedures are ineffective or impractical.
The recalled product
- Product
- ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 28,276
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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