FDAFDA · Food and drugs·Recall number Z-0213-2015
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/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
Published November 19, 2014 · Recall initiated: September 30, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Masimo Corporation
- Distributor
- Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
- Lot
- PART_ID LOT_ID 3311 11CE2 3311 E11EA7 3311 11EMM 3311 E11EDJ 3311 11FAU 3311 11FAV 3311 11CE2 3311 11FAW 3311 11GBY 3311 11HGF 3311 11HE6 3311 11J80 3311 11JCJ 3311 11HNO 3311 11JCK 3311 11K37 3412 11MA7 3311 R11KFY 3311 11K37 3311 11KQM 3311 11NDZ 3311 12B95 3412 12CP1 3412 11AM7 3449 E12HR3 3450 E12HR4 3412 12CP1 3635 12KP4 3636 12KP5 3635 12KQ7 3636 12KQ8 3450 E12KJY 3449 E12KS3 3449 E12KT4 3450 E12KS4 3635 12MAG 3450 E12KT5 3450 E12MA2 3578 E12MA6 3577 E12ME6 3449 E12KS3 3450 E12KS4 3578 R12N2U 3578 E12NB2 3577 E12NA9 3578 E12NB2 3450 E12HR4 3577 R12N2W 3449 13AYG 3450 R13BRX 3450 R13BE2 3577 R12N2W 3577 E12NA9 3315 E12JS1 3635 12N17 3450 13C57 3635 12N1S 3449 E12HR3 3578 13C59 3450 13DPZ 3578 E12NB2 3578 13C59 3636 13CNZ 3635 12N1S 3449 13EPF 3635 13C4K 3449 13C56 3449 13AYG 3449 13EPF 3636 13FPN PART_ID LOT_ID SERIAL_NUMBER 3449 2062190-001 3315 E12JS1 3449 V25060 3449 V25061 3449 V25062 3449 V25063 3449 V25064 3449 V25065 3449 V25066 3449 V25067 3449 V25068 3449 V25069 3449 V25070 3449 V25071 3449 V25072 3449 V25073 3449 V25074 3449 V25075 3449 V25076 3449 V25077 3449 V25078 3449 V25079 3449 V25080 3449 V25081 3449 V25082 3449 V25083 3449 V25084 3449 V25085 3449 V25086 3449 V25087 3449 V25088 3449 V25089 3449 V25136 3449 V25152 3449 V25154 3449 V25155 3449 V25156 3449 V25158 3449 V25164 3449 V25167 3449 V25170 3449 V25172 3449 V25174 3449 V25175 3449 V25179 3449 V25181 3449 V25255 3449 V25257 3449 V25258 3449 V25259 3449 V25262 3449 V25267 3577 V14404 3577 V14422 3577 V14464 3577 V14425 3577 V14434 3577 V14457 3577 V14465 3577 V14467 3577 V16984 3577 V17047 3577 V17088 3577 V17089 3577 V17090 3577 V17091 3577 V17092 3577 V17093 3577 V17094 3577 V17095 3577 V17097 3577
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.