Events

Check-Flo hemostasis assembly and others 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 Cook Medical Europe 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
  • 날짜
    2017-02-06
  • 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
    Cook medical begins the process of voluntarily recalling the above products and batch numbers. we have seen an increase in reports of blood loss related to devices whose design includes a special hemostatic valve (also called a "blue" valve or polyisoprene valve). in november 2015, products with blue haemostatic valves were either discontinued or replaced with products containing a different valve design with improved hemostasis. cook continued to receive reports of blood loss related to the previous generation of products with "blue" valves and therefore initiated the procedure described above in connection with these products.

Device

Check-Flo hemostasis assembly and others
  • 모델명 / 제조번호(시리얼번호)
    KCFN-4.0-18-13-RA-HC G35597 KCFN-4.0-18-23-RA-HC G35598 KCFN-4.0-18-7-RA-HC G35596 KCFN-5.0-18-13-RA-HC G35600 KCFN-5.0-18-13-RA-S-HC G35607 KCFN-5.0-18-23-RA-HC G35601 KCFN-5.0-18-7-RA-HC G35599 KCFN-6.0-18-13-RA-HC G35603 KCFN-6.0-18-13-RA-S-HC G35608 KCFN-6.0-18-23-RA-HC G35604 KCFN-6.0-18-23-RA-S-HC G35609 KCFN-6.0-18-7-RA-HC G35602 KCFN-7.0-18-13-RA-HC G35605 KCFN-7.0-18-23-RA-HC G35606 Komplet TriForce™ za periferni prehod KCXS-5.0-35-100-RB-0/0-HC G56416 KCXS-5.0-35-65-RB-0/0-HC G56412 KCXS-5.0-35-65-RB-0/DAV-HC G56413 KCXS-5.0-35-65-RB-MPB/DAV-HC G56415 Pripomoček za uvajanje Check- Flo ® Hausdorf-Lock atrijski RCFW-7.0-38-75-RB-HLA-091100- BV G03769 RCFW-8.0-38-75-RB-HLA-091100- BV G03770
  • Manufacturer
    Cook Medical Europe

Manufacturer

Cook Medical Europe