Device Recall ACS Torque Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Vascular 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
    58979
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2791-2011
  • 사례 시작날짜
    2011-01-07
  • 사례 출판 날짜
    2011-07-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-06-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Cardiovascular Torque Device - Product Code DQX
  • 원인
    Five lots of guide catheters and accessory products were processed through ethylene oxide (eto) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for eto sterilization.
  • 조치
    Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0121091
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution, and Ireland.
  • 제품 설명
    Abbott Vascular ACS .035 Torque Device || Part Number : 1003279. || For use in cardiac diagnostic or therapeutic procedures.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA