Events

Device Recall SnugFit(R) Expandable Mattress Cover 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LITTLE RAPIDS CORPORATION 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
    78899
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0578-2018
  • 사례 시작날짜
    2017-12-27
  • 사례 출판 날짜
    2018-01-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160825
  • 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
    Bedding, disposable, medical - Product Code KME
  • 원인
    The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. the product is designed for patient transfer, not lifting. however, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. lifting could lead tearing of the equipment cover and the potential for patient falling through.
  • 조치
    The firm initiated their recall by email on 12/27/2017 to their direct consignees. The consignees were directed to report back with the number of products on hand for return and to notify their customers of the recall.

Device

Device Recall SnugFit(R) Expandable Mattress Cover
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 17871, 17971, 18071, and 18971
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
  • 제품 설명
    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
  • Manufacturer
    LITTLE RAPIDS CORPORATION

Manufacturer

LITTLE RAPIDS CORPORATION
  • 제조사 주소
    LITTLE RAPIDS CORPORATION, 2273 Larsen Rd, Green Bay WI 54303-4809
  • 제조사 모회사 (2017)
    Little Rapids Corporation
  • Source
    USFDA