Events

Bassinet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nemschoff Chairs, 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
    60615
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0832-2012
  • 사례 시작날짜
    2011-10-14
  • 사례 출판 날짜
    2012-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106002
  • 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
    Bassinet, hospital - Product Code NZG
  • 원인
    To correct issues with casters, door hinges, drawer slides, and the bassinet surround. also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
  • 조치
    The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.

Device

Bassinet
  • 모델명 / 제조번호(시리얼번호)
    Model BSNT/01 and BSNT/02 manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.
  • 제품 설명
    Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 || The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
  • Manufacturer
    Nemschoff Chairs, Inc.

Manufacturer

Nemschoff Chairs, Inc.
  • 제조사 주소
    Nemschoff Chairs, Inc., 909 N 8th St, Sheboygan WI 53081-4056
  • Source
    USFDA