Recall of PERSONAL CYCLER SET WITH CASSETTE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER 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
    46652
  • Event Risk Class
    II
  • Event Initiated Date
    1999-02-08
  • 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
    May restrict delivery of medication due to an obstruction in the cassette.

Device

  • Model / Serial
    Model Catalog: 5C4469 (Lot serial: H98J26529 H98J26537 H98J275); Model Catalog: 5C4469 (Lot serial: 27 H98K30537 H98L02526 H98J); Model Catalog: 5C4469 (Lot serial: H98K03583 H98K04581 H98L0153); Model Catalog: 5C4469 (Lot serial: H98K30545 H98L02583 H98J2854); Model Catalog: 5C4469 (Lot serial: 6 H98L04589); Model Catalog: 5C4469 (Lot serial: 27535 H98J28525 H98J28533); Model Catalog: 5C4469 (Lot serial: 36 H98L04589); Model Catalog: 5C4469 (Lot serial: H98K03583 H98K04581 H98L015); Model Catalog: 5C4469 (Lot serial: 01528 H98L03581 H98K02585); Model Catalog: 5C4469 (Lot serial: 1 H98J29523 H98J30588 H98L)
  • Product Description
    PERSONAL CYCLER SET WITH CASSETTE
  • Manufacturer

Manufacturer