Events

ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone Marrow Biopsy System Tray ARROW OnControl System Sterile Procedure Tray 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Teleflex Medical Australia Pty Ltd 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-01494-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01494-1
  • 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
    Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is the potential for infection to occur.
  • 조치
    Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.

Device

ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone ...
  • 모델명 / 제조번호(시리얼번호)
    ARROW OnControl System TraysARROW OnControl Bone Lesion Biopsy System TrayARROW OnControl Bone Marrow Biopsy System TrayARROW OnControl System Sterile Procedure TrayCatalogue Numbers: 9403-EU-006, 9408-EU-006, 9411-EU-006, 9462-EU-001, 9463-EU-001, 9464-EU-001, 9466-EU-001Multiple Batch NumbersARTG Number: 264374
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd