Cytal Burn Matrix recalled over out-of-specification endotoxin test results
Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.
What this means for you
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 7x10 cm, product ID BMM0710, UDI-DI 00386190001103, is being recalled. The action covers seven units across lots 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011 and 7593013.
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 above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound dressing
- Hazard
- endotoxin
- out-of-specification
- wound-care
- class-ii
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 (8)
- Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683
- 7579681
- 7582227
- 7583891
- 7594266
- 7593018
- 7593011
- 7593013.
Distribution
Distributed nationwide across the United States.
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