Events

Radifocus® Introducer II, layer Radifocus® Introducer II M and Glidesheath SlenderTM 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Terumo Europe NV 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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