Fusion Pushing Catheter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-00852-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-07-11
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Cook medical has identified a labelling issue with the fusion pushing catheter. the graphic on the product label on the fs-pc-7 device shows the outer diameter (od) of the pushing catheter is 7fr. however, the od of the pushing catheter for the fs-pc-7 device is 6fr; therefore the od has been incorrectly represented on the label. this issue impacts the product label only.The device has always been manufactured to the correct specification (6fr) and has been shown in design verification and validation during simulated use testing that it can be effectively used with a 7fr stent (as indicated on the label that it can be used with a 7fr stent).To date, there have been no complaints or reports of injury/illness due to this issue.
  • 조치
    Cook Medical is requesting customers: 1. Examine inventory immediately to identify and quarantine affected products; 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days; 3. Return any affected products as per the instructions in the acknowledgement and receipt Form; 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (07 3841 3905) or email to cau.custserv@cookmedical.com 5. Report adverse events to Cook Medical Customer Relations at cau.custserv@cookmedical.com , or call toll free -1800 777 222 Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: cau.custserv@cookmedical.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Fusion Pushing CatheterCatalogue Identifier: FS-PC-7All Lot NumbersARTG Number: 139333
  • Manufacturer

Manufacturer