Events

Pilling Knife Handles 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-2017-RN-01280-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01280-1
  • 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 medical has identified that the slot depth of pilling knife handles are out of specification, so blades may not fit on the handles properly. if a blade does not fit properly, the user may struggle to connect the two pieces, causing them to slip and cut their hand. or, if the blade is not securely connected when the product is used in surgery, the blade could dislodge during use and fall into the body cavity. to date, teleflex medical has not received any reports of patient injuries or deaths relating to this issue.
  • 조치
    Teleflex is advising customers to quarantine all affected stock and discontinue use. Teleflex will arrange collection of affected product from impacted customers and apply credit to their accounts.

Device

Pilling Knife Handles
  • 모델명 / 제조번호(시리얼번호)
    Pilling Knife HandlesKnife Handle 3 - Straight tip, Straight shaft, 3, 4 7/8" (12.5cm)Knife Handle 3L - Straight tip, Straight shaft, 3L, 8 3/8" (21cm)Knife Handle 3LA - Angled tip, Straight shaft, 3LA, 8 1/8" (20.5cm)Knife Handle 4 - Straight tip, Straight shaft, 4, 5 3/8" (13.5cm)Knife Handle 7 Scalpel - Straight tip, Straight shaft, 7 SCALPEL, 6 3/8" (16.5cm)Multiple Product Codes and Lot NumbersARTG: 94282
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd