Device 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 series of drainage holes near the catheter's bullet shaped tip.
Z-2173-2026
Product summary
- Event
- Event 98752
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 packs (200 units)
- Official record key
device-enforcement:Z-2173-2026
Official wording
Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.
Code information: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
Distribution pattern: 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).
Derived failure modes
-
Potency or specification failure
Out-of-specification