Events

Device Recall V.A.C. Abdominal Dressing System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kinetic Concepts, 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
    35089
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0873-06
  • 사례 시작날짜
    2006-03-17
  • 사례 출판 날짜
    2006-05-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-11-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45242
  • 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
    Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
  • 조치
    Firm sent correction letters on 03/17/06 to all customers who purchased the device since May 2005.

Device

Device Recall V.A.C. Abdominal Dressing System
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: 05.13.05.01; 05.24.05.16; 06.09.05.24; 06.15.05.13; 07.06.05.08; 07.13.05.05.03; 07.14.05.06; 07.19.05.10; 07.28.05.15; 08.03.05.15; 08.10.05.15; 08.17.05.18; 08.17.05.30; 08.17.05.31; 09.07.05.23; 09.21.05.16; 09.28.05.16; 10.05.05.29; 10.19.05.22; 12.28.05.06; 01.11.06.16; 02.01.06.15; 02.01.06.16; 02.15.06.23; 02.15.06.24.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product distributed nationwide and to the following countries: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland.
  • 제품 설명
    Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
  • Manufacturer
    Kinetic Concepts, Inc

Manufacturer

Kinetic Concepts, Inc
  • 제조사 주소
    Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
  • Source
    USFDA