Events

Recall of Medisafe SureSafe Wraps and Drapes

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medisafe Industries 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
    13741
  • Event Initiated Date
    2012-11-02
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    Identified that the machinery used during the manufacturing of these particular products may have caused metal shaving, a residue of the grinding process, to be present in the finished product.To prevent recurrence of this issue the manufacturer is putting in place additional quality checks and quality control processes.
  • Action
    Product to be returned to supplier

Device

Medisafe SureSafe Wraps and Drapes
  • Model / Serial
    Model: SU-J6102, SU-J6105, SUJ6106, SU-j6108, SU-J6122, SU-J6123, SU-J6126, SU-J6130, Affected: GA120807NS, GA120808NS, GA120802NS, GA12072ONS, GA120725NS,
  • Manufacturer
    Medisafe Industries Ltd

Manufacturer

Medisafe Industries Ltd
  • Source
    NZMMDSA