Recall of Curlin Medical infusion pump

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

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
    19678
  • Event Initiated Date
    2016-01-19
  • Event Country
  • Event Source
    NZMMDSA
  • 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: Biomed Limited, 52 Carrington Road, Point Chevalier, AUCKLAND
  • Reason
    Master pumps used to calibrate curlin infusion pumps manufactured or serviced from march 18, 2015 to november 6, 2015 were out of tolerance.Use of affected pumps may cause an over-delivery of medications and solutions at a rate of 1.2 – 6.8% faster than programmed. likewise, the volume to be infused may be depleted earlier than expected, resulting in over delivery of overfill contained in the iv bag, if overfill is present. if overfill is not present, the pump may present an air in line or upstream occlusion alarm once the iv bag has emptied. the pump will stop infusing when either of these alarms occurs.
  • Action
    Product to be returned to supplier

Device

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA