Events

Bard Ventrio 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Davol, Inc., Sub. 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
    57010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0423-2011
  • 사례 시작날짜
    2010-10-15
  • 사례 출판 날짜
    2010-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95173
  • 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
    Polymeric Surgical Mesh - Product Code FTL
  • 원인
    Mislabeled: hernia patch may be a different size than on the product label.
  • 조치
    Davol notified accounts by an Urgent: Medical Device Recall letter on 10/15/10 via overnight delivery. The letter stated that the product maybe a different size than indicated on the product label. It also identified the affected product. Accounts are requested to examine their inventory, remove, and return recalled product. Customers are to notify any of their customers that they may have further distributed the affected product to by including a copy of the recall notice. Customers should contact Davol Customer Service 1-800-556-6275 for instructions on how to return the affected product. Customers are also requested to complete and fax back the attached fax sheet to 1-401-825-8753. If there are any additional questions, customers should contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Service Support Department at 1-800-562-0027.

Device

Bard Ventrio
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: HUUG1825
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    BARD¿ Ventrio¿ Large Oval Hernia Patch 5.4" x 7.0" || Product Code: 0010212 || Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

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