Events

Bard Ventralex" ST Medium Circle with Strap Hernia Patch 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
    60057
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0144-2012
  • 사례 시작날짜
    2011-10-04
  • 사례 출판 날짜
    2011-11-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104352
  • 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
    Mislabeled: bard¿ ventralex" st medium circle was packaged in a pre-printed carton identified for a bard¿ ventralex" st large circle.
  • 조치
    Davol Inc. issued an Urgent; Medical Device Recall letter on 10/4/11 for the mislabeled Bard Ventralex ST Medium Circle. The letter identified the affected product and explained the reason for recall. Customers are to immediately examine their inventory and quarantine any affected product. In addition, if any product was further distributed then those customers should be notified of the recall as well. Accounts are to contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. The attached recall effectiveness check form should be completed and returned. Questions should be directed towards Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.

Device

Bard Ventralex" ST Medium Circle with Strap Hernia Patch
  • 모델명 / 제조번호(시리얼번호)
    Lot number: HUVD1253.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. || Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars.
  • 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