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Terminated

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

FDA Recall Z-0419-2018 · Posted None

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeDWJ
Date Initiated2017-07-21
Date Terminated2018-03-22
Product Quantity11160

Reason for Recall

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).

Firm Action

Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.

Root Cause

Component design/selection

Distribution Pattern

U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101705MISTRAL-AIR WARMING SYSTEMThe Surgical Company International B.V. · 2010-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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