Events

Device Recall BC Hammock Mesh Sling 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Prism Medical Services USA 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
    65263
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1555-2013
  • 사례 시작날짜
    2013-05-23
  • 사례 출판 날짜
    2013-06-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118406
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    The product does not meet the firm's size standards, the product was produced in the incorrect size.
  • 조치
    Prism Medical contacted their US consignees on May 28, 2013 with an e-mail notification of the recall. The notification explained the Field Safety Notice Letter dated May 22, 2013. The notice identified the affected product, problem and actions to be taken. Customers were instructed to contact Customer Service at Prism Medical to receive a return goods authorization to replace the affected product at no charge. For questions call 905-850-9003 Ext. 249.

Device

Device Recall BC Hammock Mesh Sling
  • 모델명 / 제조번호(시리얼번호)
    Lot: PHM000524.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: CA, IL, OH, and TX. and country of: Canada.
  • 제품 설명
    BC Hammock Mesh Sling (Junior), product number, 537005. || Product Usage: || The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
  • Manufacturer
    Prism Medical Services USA

Manufacturer

Prism Medical Services USA
  • 제조사 주소
    Prism Medical Services USA, 45 Progress Pkwy, Maryland Heights MO 63043-3701
  • Source
    USFDA