FDAFDA · Food and drugs·Recall number Z-0477-2015
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
Published December 3, 2014 · Recall initiated: April 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ZOLL Circulation, Inc.
- Distributor
- One location in NC
- Lot
- Model 1027, Catalog number 8700-000775-01, lot 0021.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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