Safety Alert for BD PrepStain™ Vacuum Pumps

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BD Diagnostics.

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
    2012-02-13
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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
    Field safety notice: bd prepstain™ vacuum pumps medical device manufacturer, bd diagnostics, has issued a field safety notice on all models of bd prepstain™ vacuum pump (all schuco© and knf neuberger models). the manufacturer identified a potential safety hazard that the affected devices exhausts alcohol vapors during normal operation. this could cause a flammable atmosphere if the pump is kept in an enclosed space, such as a cabinet. bd is instructing customers to remove the vacuum pump from any enclosed spaces that are not well ventilated. the local supplier has provided warning label sheets to users for attachment on the affected devices. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD PrepStain™ Vacuum Pumps
  • Manufacturer

Manufacturer