Events

Device Recall Genzyme 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Genzyme Corporation 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
    62127
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1856-2012
  • 사례 시작날짜
    2012-06-13
  • 사례 출판 날짜
    2012-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109888
  • 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
    Barrier, absorable, adhesion - Product Code MCN
  • 원인
    Sterility of product may be compromised due to packaging defect.
  • 조치
    Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.

Device

Device Recall Genzyme
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 11NP685 . Exp 2014- 11
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • 제품 설명
    seprafilm¿ Single Site ADHESION BARRIER || Re-order Number: 6641-01 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • 제조사 주소
    Genzyme Corporation, 31,45,49,51,55,74,76, & 80 New York Ave., Framingham MA 01702-5733
  • 제조사 모회사 (2017)
    Sanofi
  • Source
    USFDA