Recall of Device Recall MA3320PM Premium Adult SYK MistralAir Premium Blankets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78886
  • Event Risk Class
    Class 2
  • Event Number
    Z-0419-2018
  • Event Initiated Date
    2017-07-21
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2018-03-22
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, thermal regulating - Product Code DWJ
  • 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).
  • Action
    Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.

Device

Manufacturer

  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Manufacturer Parent Company (2017)
  • Source
    USFDA