Events

Device Recall Stent Delivery Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Idev Technologies, Inc. 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
    61090
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1213-2012
  • 사례 시작날짜
    2012-01-31
  • 사례 출판 날짜
    2012-03-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107279
  • 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
    Catheter, biliary, diagnostic - Product Code FGE
  • 원인
    The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).
  • 조치
    IDEV Technologies sent an "URGENT PRODUCT RECALL" letter dated February 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to sign the letter and return a copy to the firm via fax to 281-525-2001 to indicate that they have received the notification. Contact the firm at 281-525-2052 for questions regarding the notice.

Device

Device Recall Stent Delivery Catheter
  • 모델명 / 제조번호(시리얼번호)
    Device Codes: S-04-120-120-G3 (Lot Number 05180062); S-04-040-120-G3 (Lot Numbers 05180031); S-04-060-120-G3 (Lot Number 05187032); S-05-040-120-G3 (Lot Number 05180034); S-05-060-120-G3 (Lot Number 05180035); S-05-080-120-G3 (Lot Number 05180036); S-05-100-120-G3 (Lot Number 05180037); and S-06-080-120-G3 (Lot Number 05180042).
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
  • 제품 설명
    SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. || Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
  • Manufacturer
    Idev Technologies, Inc.

Manufacturer

Idev Technologies, Inc.
  • 제조사 주소
    Idev Technologies, Inc., 253 Medical Center Blvd, Webster TX 77598
  • Source
    USFDA