Device Recall Disposable clip applier 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 EXP Pharmaceutical Services Corp 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
    71608
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2226-2015
  • 사례 시작날짜
    2015-02-11
  • 사례 출판 날짜
    2015-07-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-12-30
  • 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
    Box, battery, pocket - Product Code FCP
  • 원인
    Exp did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
  • 조치
    EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.

Device

  • 모델명 / 제조번호(시리얼번호)
    OEM Catalog number 3299.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • 제품 설명
    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 3299; || EXP (repackager), Covidien (OEM) || Clip, implantable
  • Manufacturer

Manufacturer

  • 제조사 주소
    EXP Pharmaceutical Services Corp, 48021Warm Springs Boulevard, Fremont CA 94539
  • 제조사 모회사 (2017)
  • Source
    USFDA