Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels
Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.
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: The recall involves a medical device with a potential contamination hazard (endotoxin) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity rating.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips (Model/Catalog Number 801403) due to identified higher-than-expected levels of endotoxin in the raw material used for production. This issue may have resulted in out-of-specification levels of endotoxin in the finished goods.
The recall affects 44,231 units distributed worldwide, including the United States, Canada, and numerous other countries. The products are indicated for the protection of tissue, including brain and other tissues of the central nervous system, during surgery. The recall includes all unexpired products associated with UDI_DIs 10381780514992 and 20886704036514.
Healthcare facilities and distributors should stop using the affected products and contact the recalling firm for instructions on return or disposal. Patients who have received these products should consult their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- SURG PAT XRAY 1X1 Model/Catalog Number: 801403. 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
- 44,231
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_DI: 10381780514992
- 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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