Waterpik 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Water Pik, Inc. 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
    61532
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1674-2012
  • 사례 시작날짜
    2012-04-03
  • 사례 출판 날짜
    2012-05-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-08-07
  • 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
    Irrigator, powered nasal - Product Code KMA
  • 원인
    Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
  • 조치
    Water Pik has generated a Press Release letter dated May 2012. The letter included safety information and instructions for the consumer to contact Waterpik for a replacement model if they experience water intrusion into the battery compartment of their device. For additional information go to www.waterpiksinusense.com/exchange.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots and codes manufactured between May 2010 and July 2011.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. || Product Usage: Sinus washing device to keep sinus passages clear of congestion.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Water Pik, Inc., 1730 East Prospect Road, Fort Collins CO 80553-0001
  • 제조사 모회사 (2017)
  • Source
    USFDA