Cytal Burn Matrix 10x15 cm recalled over out-of-specification endotoxin results
Cytal Burn Matrix 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 226 units are affected.
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 for out-of-specification endotoxin results in a wound-contact product, a risk of harm with no injuries reported in the source.
Plain-English summary
The Cytal Burn Matrix 10x15 cm, product ID BMM1015, UDI-DI 00386190001110, is being recalled. The action covers 226 units across the lots listed in the recall notice, including 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935 and 7593018.
The recall is due to an increased rate of out-of-specification endotoxin results. Endotoxin limits apply to products placed in contact with wounds because endotoxin can provoke a febrile or inflammatory response. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states. The dressings are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product ID, UDI-DI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound dressing
- Affected units
- 226
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)
- Product ID: BMM1015. UDI-DI: 00386190001110. Lot Numbers: 7579681
- 7582225
- 7582227
- 7583933
- 7591942
- 7591944
- 7583935
- 7593018
- 7594284
- 7593013.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Integra LifeSciences Corp. (NeuroSciences) 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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