Device Recall Kii Shielded Bladed Access System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Applied Medical Resources 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
    63842
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0644-2013
  • 사례 시작날짜
    2012-11-05
  • 사례 출판 날짜
    2013-01-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-01-16
  • 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
    Laparoscope, general & plastic surgery - Product Code CGJ
  • 원인
    Applied medical is conducting a voluntary recall on a specific lot number of its 12x150mm kii shielded bladed access systems. this is due to a potential for the blade to remain exposed after shield deployment. further use of any affected product should cease immediately. the affected model number is ctb71, and the affected lot is 1179107.
  • 조치
    Applied Medical sent an Urgent Medical Device Recall to all affected customers in November 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indcated any product their facility is returning. The Recall confirmation form should be returned to Applied Medical by emailing to recall60494844#applied medical.com or fax to 949-713-8832. Return affecte4d product and a copy of the confirmation form to Applied Medical. Customers with questions were instructed to call 949-713-8662. For questions regarding this recall 949-713-8662.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 1179107
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and France.
  • 제품 설명
    Laparoscope, general; plastic surgery || Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • 제조사 모회사 (2017)
  • Source
    USFDA