Surgical patties and strips recalled for elevated endotoxin levels in raw materials
Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.
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: FDA Class II recall of surgical devices with out-of-specification endotoxin contamination presents a risk of harm in surgical applications, but no illnesses or injuries have been reported. Per the rubric, this fits the 'High' severity tier for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips (Model 801406) due to higher-than-expected endotoxin levels in raw materials. Testing identified out-of-specification endotoxin levels in finished products.
Surgical patties and strips are medical devices indicated for protecting tissue, including brain and other central nervous system tissues, during surgery. Approximately 56,082 units have been distributed worldwide.
Endotoxin is a potentially harmful substance that may trigger immune responses. Healthcare providers should verify whether they have received affected products (Model 801406) and contact Integra LifeSciences Corp. regarding appropriate management of affected inventory.
The recalled product
- Product
- SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. 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
- 56,082
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: 10381780515012
- 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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