Events

Safety Alert for MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare 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
    2014-05-15
  • Event Date Posted
    2014-05-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140515.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: baxter minicap extended life peritoneal dialysis transfer set with twist clamp the australia therapeutic goods administration (tga) posted a medical device safety alert concerning minicap extended life peritoneal dialysis (pd) transfer set with twist clamp manufactured by baxter healthcare ltd. the affected product code is r5c4482 and only lot number h12f18054 is affected. the manufacturer has received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis. the manufacturer advises hospitals and distributors to locate and return all the affected products at their facility. health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. for details, please refer to tga websites: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00536-2 and http://www.Tga.Gov.Au/safety/alerts-device-minicap-extended-life-pd-140515.Htm according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2014.

Device

MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd