Device Recall Sit/stand Rolling Walker 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Central Purchasing LLC DBA Harbor Freight Tools 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
    67876
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1451-2014
  • 사례 시작날짜
    2014-03-27
  • 사례 출판 날짜
    2014-04-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-08-05
  • 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
    Walker, mechanical - Product Code ITJ
  • 원인
    Harbor freight tools intiaited a recall of sit/stand rolling walker (sku/item number 66838, sold june 2009 to march 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.
  • 조치
    Recall communication to web site customers who purchased the product, notifying them of recall and availability of full refund for product. Store posting notifying retail customers of the recall and availability of full refund for product (with a similar posting provided on the HFT web site). Consumers are informed of the recall, product info. with photo, item number, reason for recall, hazard, instructed to stop using these walkers immediately, and contact information provided telephone number, and e-mail address. Consumer letters also provided with a Merchandise Return Label. On 04/02/14, an updated consumer letter issued.

Device

  • 모델명 / 제조번호(시리얼번호)
    SKU/Item Number 66838, Sold June 2009 to March 2014.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Central Purchasing LLC DBA Harbor Freight Tools, 26541 Agoura Rd, Calabasas CA 91302-2093
  • 제조사 모회사 (2017)
  • Source
    USFDA