PREMIER CARE RECLINER 5570 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Winco Mfg., 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
    67377
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1114-2014
  • 사례 시작날짜
    2013-09-06
  • 사례 출판 날짜
    2014-02-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-12-30
  • 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
    Chair, with casters - Product Code INM
  • 원인
    A supplier manufacturing assembly defect with the right hand recline mechanism. use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
  • 조치
    Winco sent a Recliner Field Correction Notification letter dated September 11, 2013 to all affected consignees. The letter identified the product, the problem and action to be taken by the consignees. The consignees were instructed to complete and return the enclosed field correction response form back to Winco so they can send replacement mechanism(s) along with instructions on how to exchange the mechanism(s). Customers with questions were instructed to contact Customer Care at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 130.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model 5570. Serial numbers: 557A1100178 thru 557A100206.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA nationwide including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kanas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, Puerto Rico and Internationally to the country of Canada.
  • 제품 설명
    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. || The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • 제조사 모회사 (2017)
  • Source
    USFDA