Events

Recall of Arrow International - VPS Rhythm T-Piece

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Arrow International 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
    22938
  • Event Initiated Date
    2018-06-29
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • Reason
    The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
  • Action
    Product to be destroyed

Device

Arrow International - VPS Rhythm T-Piece

Manufacturer

Arrow International Inc