Events

Safety Alert for Zevex Ambulatory Infusion PumpsPainsmart IOD, 6000 CMS, and 4000 CMS

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

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
    2011-11-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115b.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
    Health canada type i recall: zevex ambulatory infusion pumpspainsmart iod, 6000 cms, and 4000 cms it has come to our attention that the health canada has issued a type i recall to remind healthcare providers and patients that painsmart iod, 6000 cms and 4000 cms (ambulatory infusion pumps), which are manufactured by zevex inc. (also traded as moog medical devices group), may give an inaccurate infusion. the accuracy of infusion with a syringe varies widely depending on the medication and stiction between the barrel and plunger of individual syringes. the effects of the variables have made the accuracy difficult to evaluate as each condition produces differing effects from the syringe variables. therefore, zevex is not confident in providing accuracy percentages for syringes as they may be misleading if the application conditions are also considered. as a result, the labeling will be modified to indicate the accuracy of delivery from a syringe cannot be guaranteed. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Zevex Ambulatory Infusion PumpsPainsmart IOD, 6000 CMS, and 4000 CMS
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Zevex Ambulatory Infusion Pumps Painsmart IOD, 6000 CMS, and 4000 CMS
  • Manufacturer
    Zevex Inc.

Manufacturer

Zevex Inc.
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    DH