Surgical patties recalled due to higher-than-expected endotoxin levels
Integra LifeSciences Corp. is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may have resulted in out-of-specification finished products used during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a surgical device with higher-than-expected endotoxin contamination used on sensitive neural tissue. Although no illnesses or injuries have been reported, the product represents a risk of harm due to endotoxin contamination in intraoperative devices, meeting the rubric criterion for High severity.
Plain-English summary
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801399) due to higher-than-expected levels of endotoxin detected in raw materials. This contamination may have resulted in out-of-specification endotoxin levels in finished products distributed worldwide.
The recalled products are surgical patties and strips indicated for use in protecting tissue during surgery, including the brain and other tissues of the central nervous system. Approximately 21,553 units were distributed to facilities worldwide including the United States, Canada, and numerous other countries.
Endotoxin is a bacterial toxin that can trigger immune reactions in patients. Although no illnesses or injuries have been reported to date, healthcare facilities in possession of these products should discontinue use and contact Integra LifeSciences Corp. for information regarding return or replacement.
The recalled product
- Product
- SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. 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
- 21,553
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# 10381780514954
- 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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