HIGH
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
Integra LifeSciences Corp.
Increased rate
HIGH
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...
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Quick Facts at a Glance
- Recall Date
- April 10, 2026
- Hazard Level
- HIGH
- Brand
- Integra LifeSciences Corp.
- Geographic Scope
- 1 states
Hazard Information
Out-of-specification endotoxin result that did not meet the acceptance criteria.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Letter
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Full 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: Out-of-specification endotoxin result that did not meet the acceptance criteria.. Classification: Class II. Quantity: 40 packs (200 units). 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).
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Product Classification
Product Details
Categories
Model Numbers
Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
Affected States
ALL
Report Date
May 20, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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