Events

Safety Alert for AccuFlux Elastomeric Infusion Pump

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medpro Corporation PTE LTD.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-12-06
  • Event Date Posted
    2012-12-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121206a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medpro accuflux elastomeric infusion pump the united states (us) food and drug administration (fda) issued a class i recall concerning medpro accuflux elastomeric infusion pump, model ct-0020-100h, lot 91209, manufactured by medpro corporation pte ltd, singapore. the recall was initiated because the affected lot may have a higher flow rate than specified. the use of the affected product may lead to over-administration of drug solutions to the patients. the product may fail to meet nominal flow rate of ±15%. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id =60030&w=12052012&lang=eng. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 december 2012.

Device

AccuFlux Elastomeric Infusion Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medpro AccuFlux Elastomeric Infusion Pump
  • Manufacturer
    Medpro Corporation PTE LTD

Manufacturer

Medpro Corporation PTE LTD
  • Source
    DH