Device Recall IPI Ventilator Circuit with 2 Water Traps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medex 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
    29496
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1122-04
  • 사례 시작날짜
    2004-07-12
  • 사례 출판 날짜
    2004-07-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-02-07
  • 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
    Set, Tubing And Support, Ventilator (W Harness) - Product Code BZO
  • 원인
    The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
  • 조치
    Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.

Device

  • 모델명 / 제조번호(시리얼번호)
    reorder no. 6066, lot L050
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.
  • 제품 설명
    IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641
  • Manufacturer

Manufacturer

  • 제조사 주소
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA