Events

Recall of IMMUNOSALINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EMD CHEMICALS 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
    25384
  • Event Risk Class
    II
  • Event Initiated Date
    2001-04-06
  • 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
  • Reason
    See field 14 in screen 1.

Device

IMMUNOSALINE
  • Model / Serial
    Model Catalog: RO1825-84 (Lot serial: 1050 0340 0285 & 0150); Model Catalog: R01825-82 (Lot serial: 1050 0340 0285 & 0150); Model Catalog: RO1825-86 (Lot serial: 1050 0340 0285 & 0150); Model Catalog: VW3466-2 (Lot serial: 1050 0340 0285 0150 0326); Model Catalog: VW3466-4 (Lot serial: 1050 0340 0285 0150 0326); Model Catalog: VW3466-7 (Lot serial: 1050 0340 0285 0150 0326); Model Catalog: VW3466-1 (Lot serial: 1050 0340 0285 0150 0326)
  • Product Description
    IMMUNOSALINE
  • Manufacturer
    EMD CHEMICALS INC.

Manufacturer

EMD CHEMICALS INC.
  • Manufacturer Address
    GIBBSTOWN
  • Source
    HC