Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin
Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.
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 medical device with out-of-specification endotoxin contamination. Endotoxin poses risk of pyrogenic reactions in surgical applications, particularly for sensitive procedures involving central nervous system tissue. No illnesses or injuries reported.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips (Model 801400), medical devices indicated for tissue protection during surgery, including brain and central nervous system tissue.
The recall is due to higher-than-expected endotoxin levels identified in raw materials used to manufacture these products. This resulted in finished goods with out-of-specification endotoxin levels.
Approximately 168,803 units of unexpired product were distributed worldwide to healthcare facilities and providers in numerous countries, including the United States and Canada.
The recalled product
- Product
- SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- endotoxin
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)
- UDI#: 10381780514961
- 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Distribution
Distributed nationwide across the United States.
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