Events

Field Safety Notices about Sterrad 100NX Sterilizer

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
    2013-11-14
  • Event Date Posted
    2013-12-23
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/12/23/vazno-obavestenje-o-medicinskom-sredstvu-sterrad-100nx-sterilizer-plazma-sterilizator/
  • 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
    Asp has determined that these endoscope models contain lumen material not covered by the processing claims in the sterrad® system that have been fully elucidated. these endoscopes may contain polyurethane material at the point of suction, and this material is not referenced in existing references to the treatment of internal ducts (lumens) in sterrad® systems.

Device

Sterrad 100NX Sterilizer
  • Model / Serial
    models: 11001BN1, 11002BD1, 11004BC1, 11009BC1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, 11302BDD2
  • Manufacturer
    ADVANCED STERILIZATION PRODUCTS

Manufacturer

ADVANCED STERILIZATION PRODUCTS