Events

Recall of Medline Custom Procedure Kit, incorporating Unomedical suction tubing

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medline Assembly Australia Pty 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
    18830
  • Event Initiated Date
    2015-07-08
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Reason
    Medline is recalling specified lots of the unomedical suction tubing. this tubing is a component in the medline procedure pack product code sotnzah04b., an internal assessment of convatec's product complaints confirmed that these devices were not meeting customer expectations. the connector parts for application to the suction device in these lots have failed to meet their required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction device outlets. cracking may result in loss of suction during an operation. this could result in reduced surgical site visibility (due to poor removal of fluid) and may make stemming of bleeding more difficult.
  • Action
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kit, incorporating Unomedical suction tubing
  • Model / Serial
    Model: SOTNZAH04B, Affected: CS1405587, CS1417569, CS1418438, CS1418710, CS1419278, CS1420864, CS1422092, CS1423500, CS1423501, CS1423955, CS1527665, CS1528112, CS1528978, CS1529680, CS1529789, CS1531866
  • Manufacturer
    Medline Assembly Australia Pty Ltd

Manufacturer

Medline Assembly Australia Pty Ltd