FDANovember 25, 2014device
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-p...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.
What to do
FDA enforcement status: Terminated
Brands named
nonin medicalnonin
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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