Events

Safety Alert for Multi-Med Single Lumen Catheters

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

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
    2016-12-12
  • Event Date Posted
    2016-12-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161212a.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: centurion multi-med single lumen catheters the united states food and drug administration (fda) has issued medical device safety alerts concerning multi-med single lumen catheters manufactured by centurion. the affected devices are identified as follows:- product code: foz centurion kit codes: ecvc1680, ecvc4785, m11620hkic, m11620hkicnl, m11620hs, m11620kc, m11620kcnl, m12013k, m12013knl lot numbers: 2016062150, 2016062950, 2016070650, 2016081550, 2016051050 2016053150, 2016060750, 2016061550, 2016063050, 2016072050, 2016080250, 2016091950, 2016060750, 2016072650, 2016093050, 2016101050, 2016052050, 2016062850, 2016082350, 2016082650, 2016090250, 2016050950, 2016053150, 2016060750, 2016071250, 2016080350, 2016082950, 2016060850, 2016061650, 2016062050, 2016070550, 2016071950, 2016080250, 2016090750, 2016071350, 2016072050, 2016092650, 2016100650, 2016072950, 2016082450 distribution date: 23 may 2016 to 18 oct 2016 the manufacturer is recalling the centurion convenience kits containing multi-med single lumen catheters. the catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. if this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. this can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death. customers are asked to identify and stop using the affected products in their inventory. for details, please refer to the fda website: medwatch: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm532629.Htm medical device recalls:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm532576.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2016.

Device

Multi-Med Single Lumen Catheters

Manufacturer

Centurion