Events

Device Recall Composix L/P with Echo PS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Davol, Inc., Subs. C. R. Bard, Inc. 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
    67149
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0820-2014
  • 사례 시작날짜
    2014-01-03
  • 사례 출판 날짜
    2014-01-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124782
  • 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
    Product labeling does not match product configuration.
  • 조치
    Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,

Device

Device Recall Composix L/P with Echo PS
  • 모델명 / 제조번호(시리얼번호)
    Lot# HUXG0491, HUXH0295
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
  • 제품 설명
    Composix L/P with Echo PS 6" X 8" Product Code 0144680 || The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
  • Manufacturer
    Davol, Inc., Subs. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Subs. C. R. Bard, Inc.
  • 제조사 주소
    Davol, Inc., Subs. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA