Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in 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: This FDA Class II recall involves endotoxin contamination in surgical materials used during sensitive procedures. Per the rubric, this qualifies as High severity: a risk-of-harm medical device product where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling CODMAN Surgical Patties and Strips (Model 801396), surgical materials used to protect tissue during surgery, including brain and central nervous system tissues. These products are manufactured from COTTONOID material with x-ray detectable markers and suture strings for surgical count verification.
The recall was initiated due to higher-than-expected levels of endotoxin identified in the raw material used to manufacture the patties and strips. This contamination may have resulted in out-of-specification endotoxin levels in finished products.
The recall affects approximately 1,791 units distributed worldwide, including throughout the United States and numerous international markets. Affected products are identified by lot codes UDI# 10381780514923 and 20886704036446. All unexpired products with these codes are subject to this recall.
The recalled product
- Product
- MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 1,791
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)
- Lot Code: UDI# 10381780514923
- 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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