Masimo SPO2 Sensor, ear clipadult

The following lot numbers are affected and are not specific to each cable/sensor type:   09AP8, 10AEU, 10KBN, 09CF9, 10BMN, 10MDN, 09CNS, 10FEN, 10MDN, 09KG6, 10F95, 10DUT, 09KG6, 10F95, 10DDK, 09NMN, 10BMN, 10DUT, 10A81, 10GJB, 10KBS, 09NMN, 10BMN, 10DUT, 10AEU, 10GJB, 10KBS, 10AEU, 10KBN, 10KBS, 11AGS, 11KAJ, 11CFT, 10KFP, 11N61, 11DAY, 11AGS, 11NG2, 11CFT, 11AGS, 12CNX, 11DDK, 12FMH, 12C68, 11FBS, 12GEB, 12C68, 11JBK, 12GEB, and 12FMH.

Anesthesiology Devices

2

No

Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.

Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), || Product Usage: || Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.