Events

Recall of Electric infusion pump administration set_IIa

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by BD Switzerland Sarl.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    23250
  • Event Initiated Date
    2018-06-28
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Reason
    The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). the manufacturer has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the cause leading to this issue are., 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set., 2. a higher cracking pressure of the back check valve.
  • Action
    Manufacturer to issue advice regarding use

Device

Electric infusion pump administration set_IIa
  • Model / Serial
    Model: BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 2 SmartSite Y ports, 1 BCV 294cm, BD Alaris™ Primary set, 3 SmartSite Y ports, 1 BCV 320cm, BD Alaris™ Primary set, 5 SmartSite Y ports, 1 BCV 349cm, Affected:
  • Manufacturer
    BD Switzerland Sarl

Manufacturer

BD Switzerland Sarl