Recall of Frenenuis Sleep safe Set

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

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: Fresenius Medical Care Australia Pty Ltd (NZ), 60 Pavillion Drive, Airport Oaks, AUCKLAND
  • Reason
    The manufacturer has become aware of leakages caused by overwelded coils on the patient and the drainage lines. overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes and thus leakages may occur.
  • Action
    Product to be exchanged