Sling Rope/Connector Assembly Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arjo, 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
    36680
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0249-2007
  • 사례 시작날짜
    2006-10-30
  • 사례 출판 날짜
    2006-12-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-01-18
  • 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
    lift - Product Code FSA
  • 원인
    The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
  • 조치
    Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that affected rope kits were incorrectly assembled, and could lead to the rope separating from the cone-shaped knob and causing the patient to fall back from the lift. The letters listed the specific quantities, order numbers and dates for the kits shipped to the customer, and requested the removal from use and return of the affected rope kits. Replacement rope kits were sent with the recall letters. Any questions were directed to Arjo''s Quality Department at 1-800-323-1245, ext. 6140.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model KS1019, all kits shipped between July 2006 through September 2006
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.
  • 제품 설명
    Sling Rope/Connector Assembly Kits for the Sara Power standing and raising aids; the kit is comprised of 2 x 230 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1019
  • Manufacturer

Manufacturer

  • 제조사 주소
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA