Events

Safety Alert for Precise RX Pediatric Flowmeter

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

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
    2016-07-25
  • Event Date Posted
    2016-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725b.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: invacare precise rx pediatric flowmeter health canada posted a medical device safety alert concerning invacare precise rx pediatric flowmeter [model numbers: ircpf16, ircpf16aw; lot numbers: 16bf017557, 16cf030112, 16cf030121, 16cf032024, 16cf040071, 16cf040083, 16df040094], manufactured by invacare corporation. the manufacturer has identified that the rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population, health impact specific to high oxygen saturation could result in systemic toxicity, potential lung vascular injury, or over extended period of time could cause blindness. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59460r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.

Device

Precise RX Pediatric Flowmeter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Invacare Precise RX Pediatric Flowmeter
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation