Surgical Patties and Strips Recalled for Elevated Endotoxin Contamination
Integra LifeSciences recalls 33,478 units of surgical patties and strips due to higher-than-expected endotoxin levels in raw materials that may have contaminated 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 recall for a potential contamination hazard in surgical devices used in sensitive central nervous system procedures. No illnesses or injuries have been reported to date. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.
Plain-English summary
Integra LifeSciences Corp. is recalling 33,478 units of surgical patties and strips (Model/Catalog Number 801401) due to higher-than-expected endotoxin levels identified in raw materials used to manufacture these products. Endotoxin is a bacterial contaminant that may have resulted in out-of-specification contamination levels in finished goods.
The surgical patties and strips are indicated for use in protecting tissue during surgery, particularly sensitive central nervous system tissues. The affected products were distributed worldwide to numerous countries including the United States, Canada, Germany, United Kingdom, and many others.
No illnesses or injuries have been reported in connection with this recall. Patients and healthcare providers who have received or used these devices should contact Integra LifeSciences Corp. with questions about the recall or to report any adverse events.
The recalled product
- Product
- SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. 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
- contamination
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# 10381780514978
- 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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