Events

Safety Alert for ProTrack Microcatheter

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

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
    2015-11-03
  • Event Date Posted
    2015-11-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151103a.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: baylis medical protrack microcatheter medical device manufacturer, baylis medical, has issued a medical device safety alert concerning its protrack microcatheter. the affected part and lot numbers are as follows: part number (lot number): cic35-145 (cifa131113, cifa100614, cif8100714, c1fa241014) part number (lot number): cic38-145 (cifa161013, cifa271113, cifa311213, cifa210214, cifa070314, cifa270314, cifa070514, cifa210514, cifa240614, cifa100714, cifa180814, cifa080914, cifa221014, cifa050115, cifa210115 and cifa060215). the manufacturer is voluntarily recalling 20 lots of protrack microcatheter (cic35-145, clc38-145) due to the possibility that the catheter may have circumferential cracks along its length. the cracks may result in leakage of fluids along the catheter. according to the manufacturer, there have been no adverse event reports related to this discovery. affected users are advised to immediately segregate all affected product and ensure that it will not be used. product replacement is on-going. 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 3 november 2015.

Device

ProTrack Microcatheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baylis Medical ProTrack Microcatheter
  • Manufacturer
    Baylis Medical

Manufacturer

Baylis Medical