Events

Recall of Askina Calgitrol Paste

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by B Braun Hospicare Ltd.

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
    22958
  • Event Initiated Date
    2018-05-17
  • 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: B Braun New Zealand Ltd, 23 Falcon Street, Parnell, AUCKLAND 1052
  • Reason
    The manufacturer has determined that the irradiation dose qualified for sterilization of the askina gel 15g and askina calgitrol paste was too low. the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 1x10-6.
  • Action
    Product to be returned to supplier

Device

Askina Calgitrol Paste
  • Model / Serial
    Model: , Affected: ASKINA CALGITROL PASTE (Item Code 6241510)
  • Manufacturer
    B Braun Hospicare Ltd

Manufacturer

B Braun Hospicare Ltd