Device Recall Hydrofilm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hartmann USA, 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
    58136
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1866-2011
  • 사례 시작날짜
    2011-02-11
  • 사례 출판 날짜
    2011-04-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-08-12
  • 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
    Dressing, wound and burn, occlusive - Product Code MGP
  • 원인
    Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. consignees were notified by letter on/about 02/11/2011. they were advised to examine their inventory and not to use any of the affected product and to return it to paul hartmann. a response form was included to be completed and returned to paul hartmann. they were further instructed to pass the no.
  • 조치
    Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number: 000543118
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.
  • 제품 설명
    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hartmann USA, Inc, 481 Lakeshore Pkwy, Rock Hill SC 29730-4205
  • 제조사 모회사 (2017)
  • Source
    USFDA