Events

Recall of Molnlycke Laparoscopy ProcedurePak

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
    16965
  • Event Initiated Date
    2014-07-14
  • 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
    Molnlycke health care has identified that the sterile tubing supplied in certain procedurepak® trays, may not have received an adequate sterilization dosage. this may lead to a compromise in sterility of one of the components in these trays.
  • Action
    Product to be returned to supplier

Device

Molnlycke Laparoscopy ProcedurePak
  • Model / Serial
    Model: Product Code: 97034227-00, Affected: Lots: 12136937,13220112,13205898
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB