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U.S. Department of Health and Human Services

Class 2 Device Recall 7F NeuroFlo Catheter

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  Class 2 Device Recall 7F NeuroFlo Catheter see related information
Date Initiated by Firm April 01, 2014
Date Posted December 03, 2014
Recall Status1 Terminated 3 on November 26, 2014
Recall Number Z-0477-2015
Recall Event ID 69735
HDE Number H030005 
Product Classification Catheter, neuro-vasculature, occluding balloon - Product Code PAV
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.
Code Information Model 1027, Catalog number 8700-000775-01, lot 0021.
Recalling Firm/
Manufacturer		 ZOLL Circulation, Inc.
2000 Ringwood Ave
San Jose CA 95131-1728
For Additional Information Contact James Palazzolo
408-541-2913
Manufacturer 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 2		 Other
Action Hospital was notified in April 2014 of the recall by UPS.
Quantity in Commerce 1 device
Distribution One location in NC
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = PAV and Original Applicant = ZOLL CIRCULATION
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