Nonin Medical, Inc recalls SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelen…

Recall date

November 25, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0901-2015

FDA classification

Class II

Brand / firm

Nonin Medical, Inc

Sold / distributed

To be provided later.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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-packed, 20 per shelf-box.