FDA-Device2018-02-07Class II
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Stryker Medical Division of Stryker Corporation
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).
Sold states
U.S.
Affected count
11160
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0419-2018Don't want to check this manually?
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