FDAJuly 21, 2017device
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
stryker medical divisionstrykerstryker medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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