Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arter
FDA device recall Z-0603-2014 · posted 2013-12-27 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
- Action taken
- Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MNJ
- Quantity affected
- 24,227.
- Distribution
- Nationwide Canada
- Date initiated
- 2013-06-04
- Date posted
- 2013-12-27
- Date terminated
- 2014-10-01
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WM. HARVEY OVERPRESSURE SAFETY VALVE (K820297) | C.R. Bard, Inc. | 1982-03-12 |