Codman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an out-of-specification endotoxin result. No illnesses, injuries, or deaths are reported in the source. Endotoxin is a quality-control and sterility concern for medical devices, but without reported adverse health consequences, the recall falls into the Moderate category per the rubric.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the Codman CerebroFlo EVD Catheter with Endexo Technology (Product ID: 37.550.501, Lot Number: 45322) due to an out-of-specification endotoxin result that did not meet the acceptance criteria.
The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter used for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's tip. The recall involves 40 packs containing 200 units total.
The product was distributed nationwide in Arizona, Arkansas, California, Connecticut, Florida, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Oregon, Texas, and Washington.
Healthcare providers and patients who have received or are considering use of this product should contact Integra LifeSciences for further guidance. The UDI-DI for this product is 10381780530138.
The recalled product
- Product
- Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a…
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
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 (1)
- Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
Distribution
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