FDAClass IIDecember 3, 2014

7F NeuroFlo Catheter recall

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…

Why was 7F NeuroFlo Catheter 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model 1027, Catalog number 8700-000775-01, lot 0021.

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…
Recalling firm
ZOLL Circulation, Inc.
Quantity
1 device
Distribution
One location in NC
Recall date
December 3, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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