Events

Safety Alert for MAQUET Servo Humidifier 163

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Arrow International Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-02-23
  • Event Date Posted
    2015-02-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150223b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: maquet servo humidifier 163 the united states food and drug administration (fda) posted a medical device safety alert concerning components of maquet servo humidifier 163 [model number: 01-06-8125-8; catalogue number: xkc01-06-8125-8; batch numbers: 201321, 201323, and 201324], manufactured by arrow international inc. the recall was initiated because of connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. if leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1008-2015&w=02182015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 february 2015.

Device

MAQUET Servo Humidifier 163
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: MAQUET Servo Humidifier 163
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc