Reported Nov 19, 2014 · Terminated
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous…
Masimo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Masimo Corporation · Forty Parker · Irvine, CA · 92618
Is this the product you have?
- Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system
- Shipping/PackageAll Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile
- Lot codes and dates
- PART_ID LOT_IDPART_ID LOT_ID SERIAL_NUMBER
140 of 140 codes
331111CE23311E11EA7331111EMM3311E11EDJ331111FAU331111FAV331111CE2331111FAW331111GBY331111HGF331111HE6331111J80331111JCJ331111HNO331111JCK331111K37341211MA73311R11KFY331111K37331111KQM331111NDZ331112B95341212CP1341211AM73449E12HR33450E12HR4341212CP1363512KP4363612KP5363512KQ7
1,878 of 1,878 codes
34492062190-0013315E12JS13449V250603449V250613449V250623449V250633449V250643449V250653449V250663449V250673449V250683449V250693449V250703449V250713449V250723449V250733449V250743449V250753449V250763449V250773449V250783449V250793449V250803449V250813449V250823449V250833449V250843449V250853449V250863449V25087
- PART_ID LOT_ID
- Amount recalled
- 21,754 units (21,222) in the U.S. and Puerto Rico)
Where it was sold
- Nationwide
- PR
Why it was recalled
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
This product could cause temporary or reversible health problems — stop using it.
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