Events

Recall of Blood donor set, quad-pack [46347] - HAE (BRT)

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

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
    22248
  • Event Initiated Date
    2017-11-23
  • 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
    The manufacturer has received reports of bag tubing leak on products rcb434kce and wbt434kce.
  • Action
    Product to be returned to supplier

Device

Blood donor set, quad-pack [46347] - HAE (BRT)
  • Model / Serial
    Model: , Affected: RCB434KCE, 1756273, 1756274, 1746275, 1756276
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation