7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal
FDA device recall Z-0477-2015 · posted 2014-12-03 · Terminated
Recall details
- Recalling firm
- ZOLL Circulation, Inc.
- 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.
- Action taken
- Hospital was notified in April 2014 of the recall by UPS.
- Root cause
- Other
- Status
- Terminated
- Product code
- PAV
- Quantity affected
- 1 device
- Distribution
- One location in NC
- Date initiated
- 2014-04-01
- Date posted
- 2014-12-03
- Date terminated
- 2014-11-26
- Location
- San Jose, CA
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