MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Reported: February 7, 2018 Initiated: July 21, 2017 #Z-0419-2018
Product Description
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
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).
Details
- Recalling Firm
- Stryker Medical Division of Stryker Corporation
- Units Affected
- 11160
- Distribution
- U.S.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM. Recalled by Stryker Medical Division of Stryker Corporation. Units affected: 11160.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0419-2018.
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