Recall Z-0477-2015— ZOLL Circulation, Inc.
Class II · Terminated
Class II FDA medical device recall by ZOLL Circulation, Inc., initiated 2014-04-01, terminated 2014-11-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- ZOLL Circulation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-01
- Terminated
- 2014-11-26
- Firm location
- San Jose, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.