TC pCO2 Electrodes…

Date posted by the FDA

Dec. 1, 2011

Status

Terminated

Filed by

Radiometer America Inc

Product

TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

Reason

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.

Distribution pattern

Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.

Quantity

4 units were distributed.

Codes and lots

Part Number: 945-655, Lot Code: DP-06

Recall started

Sept. 27, 2011

Device type

Monitor, Carbon-Dioxide, Cutaneous

Root cause (FDA)

Employee error

What the company told customers

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.

Recall number

Z-0341-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0341-2012. The agency record governs; check it and the company before acting.