Integra LifeSciences Corp. (NeuroSciences): 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.), 3

Hazard

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Details from the source

Reason for recall: Out-of-specification endotoxin result that did not meet the acceptance criteria. Distribution: 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). Quantity: 40 packs (200 units) Lot/code info: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

UPC codes

10381780530138

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.