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Recall Observatory FDA recall evidence

Device product

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

Z-0419-2018

July 21, 2017

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 78886
Status
Terminated
Classification
Class II
Quantity
11160
Official record key
device-enforcement:Z-0419-2018

Official wording

Reason: 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).

Code information: LOT #(s): 1640002, 1645003

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).