Events

BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venous Description:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PG 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01597-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01597-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Navilyst medical, inc., the manufacturer of the bioflo picc with pasv valve technology, is conducting a recall based on information received from greatbatch medical, who manufacturers the viapeel ptfe peelable introducer. navilyst medical has confirmed that the affected sheaths from a greatbatch medical recall of the peelable introducers (greatbatch model number 10890-006) have been included in packaged bioflo picc kits. these particular introducers have the potential for the handles to detach from the sheath during use. this may result in user dissatisfaction and/or prolonged procedure, or if both handles detach, the sheath tube could migrate into the patient leading to an unplanned surgical retrieval.. navilyst medical has received several complaints from users, but to date, there have been no reports of patient injuries as a result of this issue.
  • 조치
    Emergo is advising users to immediately stop using and quarantine the affected lot of Bioflo PICC Kits. Affected product is to be returned to the distributor Florey Medical Pty Ltd. Replacement product or credit will be issued via the distributor.

Device

BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, c...
  • 모델명 / 제조번호(시리얼번호)
    BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venousDescription:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PGItem Number: H965458830Catalogue Reference: 45-883Lot Number: 4908978Expiry: 30 June 2017 ARTG Number: 203831
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia