Events

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
    Recall
  • Event ID
    20466
  • Event Initiated Date
    2016-08-11
  • 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: MacoPharma Australia Pty Ltd, BDO Auckland, L8, 120 Albert St, Auckland 1010
  • Reason
    Side slits and hanging holes have been reported missing on the final red cell pack (cv1014 pack) of some bottom and top (bat) systems.
  • Action
    Manufacturer to issue advice regarding use

Device

Blood Donor Set/Quad/46347
  • Model / Serial
    Model: , Affected: CV1014 packs
  • Manufacturer
    Maco Pharma SA

Manufacturer

Maco Pharma SA
  • Manufacturer Parent Company (2017)
    Macopharma
  • Source
    NZMMDSA