Premier LifeCare Recliner 5400 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
    61049
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1105-2012
  • 사례 시작날짜
    2011-10-17
  • 사례 출판 날짜
    2012-02-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-04
  • 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
    On 10/17/2011 winco mfg. llc, ocala, fl initiated a recall of the premier lifecare recliner and premier care recliner models 5400 and 5570 distributed between january 4, 2011 and october 12, 2011. the position lock pin(s) could potentially fail if exposed to excessive force when the chair is in the locked recline position. this failure will result in an inoperable position lock bar feature.
  • 조치
    Winco Mfg. sent a "POSITION LOCK PIN RECALL NOTIFICATION" letter dated October 24 , 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an enclosed response form and provide product disposition. Winco will ship retro-fit parts to install on the affected product. Instructions will explain step by step, how to implement the fix. Contact Winco at 800-237-3377 for questions regarding this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model 5400
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, KS, MA, MI, MO, MS, NC, NM, NY, OK, PA, SC, SD, TN, TX, VA, WI, and the country of Canada.
  • 제품 설명
    Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" || Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 540***Serial No. 540-...***" || Press on type label: "***Model No. 557-...***Serial No.***". || Long-term multi-positional recliner.
  • Manufacturer

Manufacturer

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