Events

Safety Alert for Hickman and Leonard Central Venous Catheter kits

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

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
    2016-04-07
  • Event Date Posted
    2016-04-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160407.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: bard hickman and leonard central venous catheter kits medical device manufacturer, bard access systems, inc., has issued a medical device safety alert concerning its hickman and leonard central venous catheter kits. the affected product code numbers are as follows: code numbers: 1) 0600560 ; 2) 0600564; 3) 0600580; 4) 0600600; 5) 0600604; 6) 0600620; 7) 0600630; 8) 0600634; 9) 0600650; 10) 0600654; 11) 0606560; 12) 0606564 the manufacturer became aware that an incorrect expiration period was assigned for the introducer needle of three lots included in various central venous catheter products (hickman and leonard catheters). a 15 year expiration period was assigned to the needle lots when the actual expiration period should have been about 5 years. according to the manufacturer’s health hazard evaluation report, this issue is unlikely to pose an incremental risk of harm. the manufacturer advises affected users to refer to the field safety notice (fsn) for the proper expiration date of the kit due to the needle. this notification does not impact any consumed product or patients with these catheters implanted. the product can be used with the understanding of the correct expiration date mentioned in the fsn. 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 7 april 2016.

Device

Hickman and Leonard Central Venous Catheter kits
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bard Hickman and Leonard Central Venous Catheter kits
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems