Events

Recall of Haemonetics High Efficiency In-Process Filter System for Leucocyte Removal

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

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
    13940
  • Event Initiated Date
    2012-12-19
  • 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: Haemonetics New Zealand Limited, No 120, 300 Richmond Road, Grey Lynn, Auckland 1021
  • Reason
    There is the potential for a leak to occur, at a very low frequency, in the flexible y connector of the donor line in some whole blood collection sets.
  • Action
    Manufacturer to issue advice regarding use

Device

Haemonetics High Efficiency In-Process Filter System for Leucocyte Removal
  • Model / Serial
    Model: Model: RCB434CUP, Affected: All lots manufactured since Mar-2012
  • Manufacturer
    Pall Medical

Manufacturer

Pall Medical