Events

Recall of Molnlycke Surgical procedure

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
    18962
  • Event Initiated Date
    2015-08-10
  • 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
    Following the recall notification from convatec ltd concerning the suction tube 3m double wrap sterile, convatec ref code 530.25.300 (medsafe ref#18739) molnlycke is advising health care professionals to scrap the convatec suction tube 3m double wrap sterile contained in the procedure pak® at the time of use and instead use a single packed sterile replacement of the tubing from their stock.
  • Action
    Product to be modified

Device

Molnlycke Surgical procedure
  • Model / Serial
    Model: SKU: 97063288-02 97063288-02 97063288-02 and 97063288-02, Affected: 15031018 15074837 15176891 and 15196034
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB