FDA recall Z-0419-2018

Product

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).

Distribution

U.S.

Key facts

Status

Terminated

Initiation date

2017-07-21

Report date

2018-02-07

Termination date

2018-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0419-2018