Reported Dec 3, 2014 · Terminated
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the…
ZOLL Circulation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ZOLL Circulation, Inc. · 2000 Ringwood Ave · San Jose, CA · 95131-1728
Is this the product you have?
- 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.
- Lot codes and dates
Model 1027Catalog number 8700-000775-01lot 0021
- Amount recalled
- 1 device
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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