Events

Prime Care, Prime Plus 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Primus Medical LLC 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
    68805
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2596-2014
  • 사례 시작날짜
    2014-08-11
  • 사례 출판 날짜
    2014-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128773
  • 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
    Cover, mattress (medical purposes) - Product Code FMW
  • 원인
    The firm found that the top cover of the mattresses were delaminating.
  • 조치
    The firm sent out Urgent: Voluntary Field Correction/Removal letters, dated August 11, 2014, to all consignees with instructions for correcting the issue. Customers were to immediately examine their inventory and quarantine any affected product. Customers are to complete and return the response form provided. Questions can be directed to 1-877-638-2776.

Device

Prime Care, Prime Plus
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.
  • 제품 설명
    Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged seperately. || Model Numbers: TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. || Intended to protect inner foam layers of mattress from any fluids that may be on the mattress.
  • Manufacturer
    Primus Medical LLC

Manufacturer

Primus Medical LLC
  • 제조사 주소
    Primus Medical LLC, 8401 Southern Blvd, Boardman OH 44512-6709
  • 제조사 모회사 (2017)
    Primus Medical Llc
  • Source
    USFDA