United StatesThe Codman CerebroFlo EVD Catheter with Endexo Technology (3.3 mm/10 Fr., 35 cm polyurethane catheter, contains 5 sets; Product ID 37.550.501; UDI‑DI 10381780530138; Lot 45322; 40 packs/200 units) is being recalled by Integra LifeSciences Corp. The recall was initiated because an out‑of‑specification endotoxin result did not meet the acceptance criteria.
What's being recalled
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 series of drainage holes near the catheter's bullet shaped tip.
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States.
How to identify it
Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
The hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)