Events

Recall of Biopsy gun, side-notch

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Bard Peripheral Vascular 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
    22025
  • Event Initiated Date
    2017-09-26
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Reason
    The manufacturer has identified that the biopsy gun dispos maxcore may be at risk of having issues related to proper functioning of the device. this includes difficulty with priming and firing, failure to obtain tissue sample, and in some instances self-activating after priming.
  • Action
    Product to be returned to supplier

Device

Biopsy gun, side-notch
  • Model / Serial
    Model: , Affected: Biopsy Gun Dispos MaxCore 14gx10cm Lot numbers REBN2123, REBP1199, REBP1807, Biopsy Gun Dispos MaxCore 16gx16cm Lot numbers REBP1420, Biopsy Gun Dispos MaxCore 18gx16cm Lot numbers REBN0342,Biopsy Gun Dispos MaxCore 18gx20cm Lot numbers REBQ1014
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc