Events

ColorSafe IV Administration sets and components 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Codan Us 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
    68591
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2040-2014
  • 사례 시작날짜
    2011-08-17
  • 사례 출판 날짜
    2014-07-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128284
  • 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, administration, intravascular - Product Code FPA
  • 원인
    Codan us corporation is recalling the colorsafe iv (intravenous) product lines because they were manufactured and marketed prior to fda approval.
  • 조치
    CODAN sent a recall letter dated August 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any of the affected product. If they sold the product they should provide Codan the name and address of the customer. so that they may be contacted to retrieve the shipped products. Customers were instructed to contact CODAN Customers Service for a Returned Goods Authorization. Customers with questions were instructed to call 714-430-1303. Customers were instructed to not send used devices.For questions regarding this recall call 714-545-2111.

Device

ColorSafe IV Administration sets and components
  • 모델명 / 제조번호(시리얼번호)
    Lot No.  71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
  • 제품 설명
    ColorSafe IV lines || Catalog No.(Model No.) || CS3000-R (76.7806), || CS400-R (76.7800), || CS408N-R (76.8000), || CS3000-B (76.7807), || B314 (25.7406), || CS400-B (76.7801), || CS408N-B (76.8001), || CS3000-O (76.7808), || CS400-O (76.7802), || CS408N-O (76.8002), || CS3000-G (76.7809), || CS400-G (76.7803), || CS408N-G (76.8004), || CS3000-P (76.7810), || CS400-P (76.7804), || CS408N-P (76.8003). || Intravenous administration sets
  • Manufacturer
    Codan Us Corporation

Manufacturer

Codan Us Corporation
  • 제조사 주소
    Codan Us Corporation, 3511 W Sunflower Ave, Santa Ana CA 92704-6944
  • 제조사 모회사 (2017)
    Codan Medical Holding Aps
  • Source
    USFDA