Events

Safety Alert for Haemodialysis bloodline for 4008 dialysis machine

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

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
    2015-04-15
  • Event Date Posted
    2015-04-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150415c.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: fresenius medical care haemodialysis bloodline for 4008 dialysis machine medical device manufacturer, fresenius medical care, has issued a medical device safety alert concerning haemodialysis bloodline for 4008 dialysis machine [article numbers: i) ap16661 av-set b dt inf-e; ii) ap16843 av-set dt-e. batch numbers: i) vhc231, vhc231a, vic252, vkc262, vlc202, vmc261; ii) vhc012, vic011, vic033, vic192, vic251, vic263, vic291, vkc042, vkc071, vkc094, vkc301, vlc032, vmc041, vmc172, vmc193, wac114, wac143, wac163, wac191, wac221, wac312]. the manufacturer has observed an increased likelihood of blood leakage between dialyzer connector and tubing during post marketing surveillance. it has been determined that a supplied material used in the dialyzer connector manufactured between august 2014 and march 2015 is causing a weak seal between the connector and tubing. the manufacturer has corrected this issue with an alternate approved and validated connector material. users are advised to stop using the affected products immediately. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2015.

Device

Haemodialysis bloodline for 4008 dialysis machine
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fresenius Medical Care Haemodialysis bloodline for 4008 dialysis machine
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care