Events

Recall of STRATUS FMMZ DIGOXIN KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE INTERNATIONAL INC..

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
    32309
  • Event Risk Class
    III
  • Event Initiated Date
    1995-03-21
  • Event Country
    Canada
  • 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

Device

STRATUS FMMZ DIGOXIN KIT
  • Model / Serial
    Model Catalog: B5700-10 (Lot serial: 2140 2143-2150 2154-2168); Model Catalog: B5700-10 (Lot serial: KIT LOT #S XDK2134 2139-); Model Catalog: B5700-10 (Lot serial: 2170-2180 2182-2258 XDK-14S); Model Catalog: B5700-10 (Lot serial: THROUGH 16S)
  • Manufacturer
    DADE INTERNATIONAL INC.

Manufacturer

DADE INTERNATIONAL INC.
  • Manufacturer Address
    MIAMI
  • Source
    HC