Cytal Wound Matrix recalled over out-of-specification endotoxin test results
Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 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 Wound Matrix 2-Layer 7x10 cm, product ID WSM0710, UDI-DI 00386190001448, is being recalled. The action covers 46 units across multiple lots listed in the recall notice, including 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942 and 7591944.
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 Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
- 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 (15)
- Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683
- 7582225
- 7583893
- 7582227
- 7583933
- 7583891
- 7591942
- 7591944
- 7583935
- 7594266
- 7594288
- 7594286
- 7593011
- 7594284
- 7593013.
Distribution
Distributed nationwide across the United States.
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