Recall Z-0477-2015
ZOLL Circulation, Inc. · initiated April 1, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model 1027, Catalog number 8700-000775-01, lot 0021.
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.
FDA-determined cause: Other
Action taken
Hospital was notified in April 2014 of the recall by UPS.
Details
- Recall number
- Z-0477-2015
- Initiated
- April 1, 2014
- Posted by FDA
- December 3, 2014
- Terminated
- November 26, 2014
- Product code
- PAV – Catheter, Neuro-Vasculature, Occluding Balloon
- Quantity
- 1 device
- Distribution
- One location in NC
- Recalling firm
- ZOLL Circulation, Inc., San Jose, CA