Recall of INVACARE PEDIATRIC FLOWMETER ACCESSORY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INVACARE 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
    109777
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-23
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    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.

Device

  • Model / Serial
    Model Catalog: IRCPF16AW (Lot serial: 16BF017557); Model Catalog: IRCPF16 (Lot serial: 16BF017557); Model Catalog: IRCPF16AW (Lot serial: 16DF040094); Model Catalog: IRCPF16 (Lot serial: 16DF040094); Model Catalog: IRCPF16AW (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040071); Model Catalog: IRCPF16 (Lot serial: 16CF030121); Model Catalog: IRCPF16AW (Lot serial: 16CF030112); Model Catalog: IRCPF16 (Lot serial: 16CF030112); Model Catalog: IRCPF16AW (Lot serial: 16CF032024); Model Catalog: IRCPF16 (Lot serial: 16CF032024); Model Catalog: IRCPF16AW (Lot serial: 16CF040071); Model Catalog: IRCPF16AW (Lot serial: 16CF030121)
  • Product Description
    INVACARE PRECISE RX PEDIATRIC FLOWMETER
  • Manufacturer

Manufacturer