Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin
Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification 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 is an FDA Class II medical device recall. Endotoxin in surgical devices represents a risk-of-harm product. Without reported hospitalizations or illnesses, this falls into the High (3) category per the rubric criterion for risk-of-harm products without confirmed injury.
Plain-English summary
Integra LifeSciences Corp. is recalling Surgical Patties and Strips (Model/Catalog Number 801449). These medical devices are indicated for protection of tissue during surgery, including brain and other tissues of the central nervous system.
The recall was initiated due to identification of higher-than-expected levels of endotoxin in raw materials used to manufacture these devices. These elevated endotoxin levels may have resulted in out-of-specification endotoxin in finished goods.
Approximately 826 units were distributed worldwide, including to the United States, Canada, Germany, United Kingdom, Australia, and numerous other countries.
The recalled product
- Product
- SURG STRP 1/8X6 Model/Catalog Number: 801449. 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.
- Category
- Medical Device — Surgical Tools
- Hazard
- Affected units
- 826
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: 10381780515050
- 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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