Events

Field Safety Notices about STERRAD CycleSure 24 Biological Indicator

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
    2013-11-28
  • Event Date Posted
    2014-03-01
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/01/03/vazno-obavestenje-o-medicinskom-sredstvu-sterrad-cyclesure-24-biological-indicator-bioloski-indikator-sterilizacije/j&j
  • 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 purpose of this announcement is to inform you that advanced sterilization products (asp) has identified microscopically intermittent low-frequency flow in the outer vial of the sterrad® cyclesure® 24 biological indicator. this flow may come from a crack or a tiny hole in the product bottle. these tiny holes can allow the medium in the vial of the biological indicator to evaporate or leak after activating the media ampoule. this may result in an inability to read the result.

Device

STERRAD CycleSure 24 Biological Indicator
  • Model / Serial
    14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 Lot br. 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106
  • Manufacturer
    ADVANCED STERILIZATION PRODUCTS

Manufacturer

ADVANCED STERILIZATION PRODUCTS