Recall of Blood Donor Set/Quad/46347

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Maco Pharma SA.

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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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: MacoPharma Australia Pty Ltd, BDO Auckland, L8, 120 Albert St, Auckland 1010
  • Reason
    The manufacturer was informed of a number of fast filtrations on the reference npt6280la. this has caused an absence of effective filtration through the media of the lcrd2 filter. this defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress.
  • Action
    Manufacturer to issue advice regarding use


  • Model / Serial
    Model: , Affected: filter type LCRD2
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source