FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano FloWire Doppler guide wire is a single
FDA device recall Z-0935-2012 · posted 2012-02-01 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
- Action taken
- Volcano Corporation sent recall letters dated October 6, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and fax the attached Customer Reply Letter so that an RMA could be issued for the return of the unused affected product, and any replacement or credit could be arranged. Customers were instructed to return the Customer Reply letter even if they no longer have the affected product in their inventory. For questions regarding the use of the product. customers were instructed to contact their Sales Representative. For questions regarding this recall call 916-281-2790.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 14 in US; 42 to EU and 15 to Japan
- Distribution
- Worldwide Distribution - USA including MI, AZ and FL and the countries of Japan and Europe
- Date initiated
- 2009-10-06
- Date posted
- 2012-02-01
- Date terminated
- 2012-02-01
- Location
- Rancho Cordova, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (K972762) | Cardio Metrics, Inc. | 1997-10-14 |