Events

Recall of Hill-Rom Clin Activ and Clin Activ Plus Therapy Surface

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hill-Rom SAS.

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
    15645
  • Event Initiated Date
    2013-12-13
  • 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: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Reason
    Manufacturer has become aware of a possible hazardous situation when silicon oil contained in the vario sensor within the clinactiv therapy surface is accidentally released. when the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor.
  • Action
    Instructions for use to be updated

Device

Hill-Rom Clin Activ and Clin Activ Plus Therapy Surface
  • Model / Serial
    Model: N02050, N02051, P02062, P02063, P02064, P02065, Affected: All lots
  • Manufacturer
    Hill-Rom SAS

Manufacturer

Hill-Rom SAS