Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
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 a Class II FDA recall of a risk-of-harm surgical device used in invasive procedures involving sensitive tissues. Endotoxin is a high-risk biological contaminant with potential to cause systemic reactions. No illnesses or injuries have been reported, maintaining the score at High rather than Severe.
Plain-English summary
Integra LifeSciences Corp. is recalling 1,222 Surgical Patties and Strips (Model/Catalog Number 801455). These sterile surgical devices are used to protect tissue, including brain and other central nervous system tissues, during surgical procedures.
The recall is due to identification of higher-than-expected levels of endotoxin in the raw material used to manufacture the product. This contamination may have resulted in finished devices with out-of-specification endotoxin levels. Endotoxin is a bacterial substance that can trigger immune system reactions.
The affected devices have been distributed worldwide to numerous countries. Products distributed under both the Integra LifeSciences name and under a previous manufacturer's name (during a transition agreement) are included in this recall. The devices are identified by UDI-DI numbers 10381780515111 and 20886704036637, with all unexpired products affected.
The recalled product
- Product
- SURG STRP 2X6 Model/Catalog Number: 801455. 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
- Affected units
- 1,222
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: 10381780515111
- 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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