Medical device recalls Moderate risk

Stryker Medical Division of Stryker Corporation recalls MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

Recall date
July 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0419-2018
FDA classification
Class II
Brand / firm
Stryker Medical Division of Stryker Corporation
Sold / distributed
U.S.

Why it was recalled

It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).

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

What was recalled

MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

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