Events

Recall of Sterilisation Process Indicators - Enzymatic/ chemical

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by 3M Health Care Group.

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
    21424
  • Event Initiated Date
    2017-05-15
  • 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: 3M New Zealand Ltd, 250 Archers Road, Glenfield, AUCKLAND 0627
  • Reason
    The manufacturer has confirmed that some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • Action
    Product to be exchanged

Device

Sterilisation Process Indicators - Enzymatic/ chemical
  • Model / Serial
    Model: , Affected: Roll Size 1322-24MM, Lot 2018-04RA, 2018-05RB, 2018-06RC, 2018-06RD. Roll Size 1355-18MM, Lot 2018-04RA, 2018-05RB, 2018-06RD. Roll Size 1355-24MM, Lot: 2018-04RA, 2018-05RB, 2018-06RD
  • Manufacturer
    3M Health Care Group

Manufacturer

3M Health Care Group
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NZMMDSA