Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functiona…

Recall date

June 29, 2015

Source

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

Recall number

Z-2267-2015

FDA classification

Class II

Brand / firm

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Sold / distributed

Worldwide Distribution - US Nationwide including Canada.

Why it was recalled

Potential missing segments on the display that can result in misinterpretation of data.

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

What was recalled

OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.