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 d
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
- 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.
- Reason / hazard
- Out-of-specification endotoxin result that did not meet the acceptance criteria.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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).
- Recall initiated
- 2026-04-10
- Code info
- Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
- Product quantity
- 40 packs (200 units)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Princeton
- State
- NJ
- Country
- United States
- Event id
- 98752
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