TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the
FDA device recall Z-0341-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.
- Action taken
- Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 4 units were distributed.
- Distribution
- Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
- Date initiated
- 2011-09-27
- Date posted
- 2011-12-01
- Date terminated
- 2012-02-19
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TCM40 MONITORING SYSTEM (K043003) | Radiometer Medical Aps | 2005-03-01 |