Events

Device Recall AMPLATZER Delivery Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGA Medical Corporation 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
    30481
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0352-05
  • 사례 시작날짜
    2004-11-23
  • 사례 출판 날짜
    2004-12-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36271
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    unknown device name - Product Code GBK
  • 원인
    Tubing utilized in the manufacture of the amplatzer delivery and exchange system sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
  • 조치
    Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.

Device

Device Recall AMPLATZER Delivery Systems
  • 모델명 / 제조번호(시리얼번호)
    M01K01-6, M02C12-24, M02C25-15, M02F05-23, M02F24-05, M02L02-21, M03A09-10, M03A09-15, M03A20-10, M03B20-17 M03C24-14, M03F02-17, M03G23-08, M03H12-42, M03J19-07 M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14 M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23 M04H03-23, M04J17-07, M04K07-02
  • 유통
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • 제품 설명
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • 제조사 주소
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA