Events

Recall of INFUSION PUMPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDEX 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
    19266
  • Event Risk Class
    II
  • Event Initiated Date
    2003-08-26
  • 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
    If pump is used with extracorporeal membrane oxygenation it is possible for ecmo circuit to generate enough negative pressure to pull syringe plunger from holder resulting in uncontrolled fluid flow.

Device

INFUSION PUMPS
  • Model / Serial
    Model Catalog: 2001 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2010IZE (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2010I (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2010HZE (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2001H (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2010 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2001NFHU (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2001HZE (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2010H (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Product Description
    2000 SERIES SYRINGE INFUSION PUMPS
  • Manufacturer
    MEDEX INC.

Manufacturer

MEDEX INC.
  • Manufacturer Address
    DULUTH
  • Source
    HC