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.
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 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
- Affected units
- 168,803
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
Part of a larger recall action
This product is one of 22 recalled by Integra LifeSciences Corp. 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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