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.
- Company
- Zoll Circulation, Inc.
- Recall Initiated
- April 1, 2014
- Posted
- December 3, 2014
- Terminated
- November 26, 2014
- Recall Number
- Z-0477-2015
- Quantity
- 1 device
- Firm Location
- San Jose, CA
Reason for Recall
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.
Distribution
One location in NC
Lot / Code Info
Model 1027, Catalog number 8700-000775-01, lot 0021.
Root Cause
Other
Action Taken
Hospital was notified in April 2014 of the recall by UPS.
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