Events

Field Safety Notices about STERRAD CycleSure 24 Biological Indicator, STERRAD CYCLESURE 24 Test Pack, STERRAD NX Test Pack, STERRAD 100NX EXPRESS Cycle Test Pack, STERRAD 50/100S Sterilizer CYCLESURE 24 Validation Kit, STERRAD 200 Sterilizer CYCLESURE 24 Validation Kit, STERRAD NX Validation Kit, STERRAD 100NX Validation Kit, STERRAD 100NX EXPRESS Cycle Validation Kit

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by ADVANCED STERILIZATION PRODUCTS.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2012-06-11
  • Event Date Posted
    2012-11-14
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/11/14/vazno-obavestenje-o-medicinskom-sredstvu-sterrad-cyclesure-24-biological-indicator-bioloski-indikatori-sterilizacije/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has determined that the stated models and series of this medicinal product are 9 months shorter than the stated shelf life, and therefore recommended that consumers stop using the specified biological sterilization indicators given that they have expired.

Device

STERRAD CycleSure 24 Biological Indicator, STERRAD CYCLESURE 24 Test Pack, STERRAD NX Test Pack, ...

Manufacturer

ADVANCED STERILIZATION PRODUCTS