Events

Safety Alert for NextStep Antegrade Chronic Hemodialysis Catheter

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

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
    2011-08-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110805.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
    Fda class i recall: arrow nextstep antegrade chronic hemodialysis catheter manufactured between april 14, 2011 and may 9, 2011 it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall to healthcare professionals followed by complaints received by the manufacturer indicating breakage and/or separation of the stylet within the arrow nextstep antegrade catheters. the arrow nextstep antegrade catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. affected models include: model no. lot no. cs-15192-ixm rv1034909 cs-15232-ixm rv1034911 cs-15272-ixm rv1034912 cs-15312-ixm rv1034913 cs-15422-ix rv1034914 cs-15502-ix rv1034915 according to the supplier, the affected product was not distributed in hong kong. if you happen to have the affected product in hand, you are advised to contact your supplier for necessary actions. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266463.Htm.

Device

NextStep Antegrade Chronic Hemodialysis Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [5 Aug 2011] Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between Apr 14, 2011 and May 9, 2011
  • Manufacturer
    Arrow

Manufacturer

Arrow