Surgical Patties and Strips Recalled for Endotoxin Contamination
Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.
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 is an FDA Class II medical device with no reported illnesses or injuries. The contamination creates potential for serious complications in sensitive surgical applications including brain surgery, but no adverse events have been documented. Per the severity rubric, this qualifies as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Surgical patties and strips (Model 801404) manufactured by Integra LifeSciences Corp. are being recalled. These medical devices are used during surgery to protect tissues, including brain and central nervous system tissues.
The recall was issued because elevated endotoxin levels were identified in raw materials used to manufacture the product, potentially resulting in finished goods with out-of-specification endotoxin levels. Endotoxin is a bacterial component that can trigger adverse reactions. No illnesses or injuries have been reported in connection with this recall.
The affected products have been distributed worldwide, including to countries across North America, Europe, Asia, and Africa. A total of 69,179 units are subject to the recall.
The recalled product
- Product
- SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. 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-DI: 10381780515005
- 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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