Events

Recall of Molnlycke Surgical 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
    15533
  • Event Initiated Date
    2013-10-21
  • 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
    The manufacturer has determined that some units of the basin liners provided in the pack, have small holes in them which could be undetectable in normal use. although the instructions for use of the basin liner itself clearly state that it should not be used to hold fluids or material for invasive use, these holes could, if present potentially compromise the sterile field.
  • Action
    Manufacturer to issue advice regarding use

Device

Molnlycke Surgical ProcedurePak
  • Model / Serial
    Model: Codes: 97020182-01, 97020184-01, 97020185-02, 97044862-01, 97044864-02, Affected: Various lots
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB