Device Recall Prolene Mesh 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    27654
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0243-04
  • 사례 시작날짜
    2003-11-03
  • 사례 출판 날짜
    2003-12-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-11-18
  • 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
    Mesh, Surgical, Polymeric - Product Code FTL
  • 원인
    Counterfeit mesh product labeled as ethicon prolene polypropylene mesh, product code pmii.
  • 조치
    Cardinal Health notified all of their hospital accounts who ordered catalog PMII by letter dated 11/3/03, alerting them to the two lots identifed as counterfeit and requesting the accounts to place all lots on hold in quarantine until further instructions are received. The accounts were requested to call Cardinal Health Customer Service at 800-964-5227 to arrange for product replacement. Cardinal Health customers were sent a follow-up letter dated 11/11/03 with product disposition information, instructing them to return all products bearing lot numbers RBE609 and RJJ130 and all boxes of Prolene with orange dots on the end of the box to Cardinal Health, and to closely examine any remaining boxes to the labeling posted on Ethicon''s website www.Ethicon.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07  Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA