Z-2173-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- April 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 packs (200 units)
Product Description
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.
Reason for Recall
Out-of-specification endotoxin result that did not meet the acceptance criteria.
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).
Code Information
Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.