Events

Device Recall GelE Donut, Squishon 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Childrens Medical Ventures 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
    68443
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2192-2014
  • 사례 시작날짜
    2014-05-28
  • 사례 출판 날짜
    2014-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127715
  • 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
    Protector, skin pressure - Product Code FMP
  • 원인
    The gel-filled gel-e donut and squishon product line has received a number of complaints about visible mold. the mold detected was determined to be cladosporium and penicillium fungi, which are commonly found molds.
  • 조치
    Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:

Device

Device Recall GelE Donut, Squishon 2
  • 모델명 / 제조번호(시리얼번호)
    All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the country of Canada.
  • 제품 설명
    Gel-E Donut, Squishon 2 gel pillows || Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • 제조사 주소
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA