Recall of Macopharma blood bags

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by MacoPharma Australia Pty Ltd.

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 Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (bat) systems.The slits cut into the cv1014 pack are used to store the crossmatch line ‘pig-tails’. the hanging loop is used during the inversion of the pack to run additive into the concentrate red cells. this recall action was undertaken prior to consultation with the tga.
  • Action
    Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016.


  • Model / Serial
    Macopharma blood bagsProduct Code: LQT6283LBMultiple batches affectedARTG Number: 142856
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source