Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
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: FDA Class II recall of a surgical hemostatic device. No illnesses or injuries have been reported. The potential loss of product effectiveness is theoretical rather than confirmed, placing this at score 3 per the rubric: unconfirmed theoretical hazards without reported injury score at most 3.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (product reference 2994), a hemostatic agent used as an adjunct to control bleeding during surgical procedures when conventional methods are ineffective or impractical.
The recall was issued due to facility temperature excursions from June through August 2021, prior to product delivery. Exposure to higher temperatures may have impacted the product's effectiveness. All lots distributed between June 1, 2021 and September 30, 2021 are included in this recall.
The product was distributed nationwide. This is classified as a Class II recall by the FDA.
The recalled product
- Product
- Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective…
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 2
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 (2)
- GTIN: 15712123000288
- 25712123000285 Lot 262801 Lots Distributed: 6/1/2021 - 6/2/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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