Molnlycke Recalls Brennen Skin Graft Mesher Due to Sterilization Failure
Molnlycke Health Care is recalling 956 units of the Brennen Skin Graft Mesher because of a sterilization validation failure. The instruments were distributed domestically and internationally.
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. The hazard involves a sterilization validation failure, which poses a risk of infection or harm to patients, but the source text does not report any specific illnesses or injuries, placing it in the High severity category.
Plain-English summary
Molnlycke Health Care, Inc. is recalling 956 units of the Brennen Skin Graft Mesher, a surgical instrument designed to expand skin grafts. The recall was initiated due to a sterilization validation failure.
The affected products include items with codes 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504, and 131506. These units were distributed nationwide in the United States and in numerous foreign countries, including Austria, Australia, Canada, Germany, France, Great Britain, India, Italy, and Japan.
Healthcare facilities and consumers should stop using the recalled instruments and contact Molnlycke Health Care for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
- Manufacturer
- Molnlycke Health Care, Inc
- Hazard
- Affected units
- 956
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 (10)
- Code: 131600
- 131601
- 131602
- 131603
- 131604
- 131500
- 131501
- 131502
- 131503
- 131504 and 131506.
Distribution
Distributed nationwide across the United States.
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