Surgical Patties and Strips recalled for endotoxin contamination in raw materials
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.
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 with no reported hospitalizations or illnesses. Endotoxin contamination is a high-risk concern for sterile surgical devices, particularly those used in brain and nervous system procedures where any microbial contamination poses significant risk of infection.
Plain-English summary
Integra LifeSciences Corp. is recalling Surgical Patties and Strips, Model 801457, due to higher-than-expected levels of endotoxin in raw materials used to manufacture the products. This contamination may have resulted in out-of-specification endotoxin levels in the finished medical devices.
These surgical patties and strips are sterile medical devices indicated for protecting tissue during surgery, including brain tissue and other tissues of the central nervous system. The recall involves 3,494 units distributed worldwide, including to facilities in the United States, Canada, and many other countries.
Healthcare providers with affected inventory should quarantine the products and review records to identify and remove any unexpired units from clinical use. Contact Integra LifeSciences for instructions regarding the recalled products.
The recalled product
- Product
- SURG STRP 3-1/2X6 Model/Catalog Number:801457. 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
- 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: 10381780515135
- 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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