Medical device recalls Moderate risk

O-Two Medical Technologies, Inc. recalls O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

Recall date
May 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2885-2018
FDA classification
Class II
Brand / firm
O-Two Medical Technologies, Inc.
Sold / distributed
AK, CA, FL

Why it was recalled

Higher levels of nitrous oxide delivered than specification

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

What was recalled

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

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