Events

Field Safety Notices about Radifocus® Introducer II, layer Radifocus® Introducer II M and Glidesheath SlenderTM

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Terumo Europe NV.

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
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Terumo corporation (japan) conducts global and voluntary recall of selected lots of radifocus introducer ii products, radifocus introducer ii m layers and glidesheath slender, which used to support transradial or transfemoral intervention procedures. the reason for the recall is a possible loss of package integrity, which could compromise the sterility of the product. this problem was identified by terumo during a routine inspection when an incomplete packaging seal was observed kits.

Device

Radifocus® Introducer II, layer Radifocus® Introducer II M and Glidesheath SlenderTM
  • Model / Serial
    RS*A10K10SQ Radifocus® Introducer II 161101, 161207 RS*A11K10SQ Radifocus® Introducer II 161129, 161207, 170113, 170116 RS*A40G05SQ Radifocus® Introducer II 161122, 161202, 170112 RS*A40G07SQ Radifocus® Introducer II 161117 RS*A40K10AQ Radifocus® Introducer II 161118 RS*A50G07SQ Radifocus® Introducer II 170109 RS*A50K10SQ Radifocus® Introducer II 161212 RS*A60G05SQ Radifocus® Introducer II 161031, 161130 RS*A60G07SQ Radifocus® Introducer II 170109 RS*A70K10SQ Radifocus® Introducer II 161031 RS*A90K10SQ Radifocus® Introducer II 161109, 161202, 170109, 170202 RS*B10K10MQ Radifocus® Introducer II 161213 RS*B10N10MQ Radifocus® Introducer II 161128, 161208, 170110 RS*B10N25AQ Radifocus® Introducer II 161104 RS*B11K10MQ Radifocus® Introducer II 161107, 161209, 170116 RS*B11N10MQ Radifocus® Introducer II 161114, 161212, 170201, 170202 RS*B11N10SQ Radifocus® Introducer II 161111, 161212, 170113 RS*B11N25AQ Radifocus® Introducer II 161115, 161212 RS*B40G07SQ Radifocus® Introducer II 161202 RS*B40K10AQ Radifocus® Introducer II 161209 RS*B50G07SQ Radifocus® Introducer II 161201 RS*B60N10MQ Radifocus® Introducer II 161125, 161222 RS*B90K10MQ Radifocus® Introducer II 161102, 161201 RS*B90N10MQ Radifocus® Introducer II 161103, 161206 RS*B90N10SQ Radifocus® Introducer II 161111, 161206, 170113 RS*B90N25AQ Radifocus® Introducer II 161108, 161202, 170110 RS*R50N10MQ Radifocus® Introducer II 161124 RS*R60N10MQ Radifocus® Introducer II 161129, 161213 RS*R80N10MQ Radifocus® Introducer II 161207 RS*R90N10MQ Radifocus® Introducer II 161108, 161121, 161205, 170201
  • Manufacturer
    Terumo Europe NV

Manufacturer

Terumo Europe NV