Events

Device Recall Shower Seat, Nonrotating 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nutech Manufacturing Corp 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
    53161
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0464-2010
  • 사례 시작날짜
    2009-07-09
  • 사례 출판 날짜
    2009-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85907
  • 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
    Transfer Aid - Product Code IKX
  • 원인
    Safety chair used in shower/bath may not meet specifications for weight load.
  • 조치
    The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.

Device

Device Recall Shower Seat, Nonrotating
  • 모델명 / 제조번호(시리얼번호)
    Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Shower Seat, Non-rotating, Catalog number 727152000
  • Manufacturer
    Nutech Manufacturing Corp

Manufacturer

Nutech Manufacturing Corp
  • 제조사 주소
    Nutech Manufacturing Corp, 2024 Broad Street, PO Box 840, Pocomoke City MD 21851-0840
  • Source
    USFDA