Events

Recall of Surgical Gown

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

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
    22306
  • Event Initiated Date
    2017-11-22
  • 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: Molnlycke Health Care Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Manukau 2022
  • Reason
    During standard rigorous quality checking, the manufacturer has self-identified a quality issue with specific batches released between october 6th till october 16th, 2017. the issue indentified particles on the products.
  • Action
    Product to be returned to supplier

Device

Surgical Gown
  • Model / Serial
    Model: , Affected: Surgical Gown UL SP L, XL, XLL, XXLL codes, 6801021-01, 680103-01, 680104-01, 6801041-01, 6801051-01, 6801061-01, 690102-01, 6901021-01, 690104-01, 6901041-01
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB