Horizon 24 Large Titanium Clips with Adhesive Backing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 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
    74669
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2327-2016
  • 사례 시작날짜
    2013-08-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-15
  • 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
    Clip, implantable - Product Code FZP
  • 원인
    The manufacturing and expiration dates are not printed on the blister pack label.
  • 조치
    Teleflex sent an Urgent Medical Device Recall Notification dated August 8, 2013, to all affected customers. The letter requested that they quarantine the product and to return it to Teleflex. An acknowledgment form was included with the letter which also was to be returned to Teleflex. A separate letter was sent to distributors requesting they conduct a sub-recall. If you have any further questions, please call (610) 378-0131.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial Number 01J1200435
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada
  • 제품 설명
    Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. || The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville NC 27560-5437
  • 제조사 모회사 (2017)
  • Source
    USFDA