Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ...
Reason for Recall / Hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 98752 |
| Address 1 | 1100 Campus Rd |
| Code info | Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322. |
| Postal code | 08540-6650 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 40 packs (200 units) |
| Reason for recall | Out-of-specification endotoxin result that did not meet the acceptance criteria. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Initial firm notification | Letter |
| Center classification date | 20260513 |
Overview
- Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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).