Device Recall Corflo AntiI.V. NG Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    48726
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2306-2008
  • 사례 시작날짜
    2008-06-25
  • 사례 출판 날짜
    2008-09-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-09-26
  • 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
    Tube - Product Code KNT
  • 원인
    The male luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.
  • 조치
    Cardinal Health notified the accounts who ordered the affected feeding tubes via letter dated 6/25/08, informing them that the feeding tube may have the wrong male Luer adapter component, which can cause leakage around the tube outside of the body. Upon review of the letter, the accounts were requested to inspect their inventory and immediately destroy any affected product found and to telephone Cardinal Health/VIASYS MedSystems Technical Service at 1-800-323-6305 for arrange for credit. Dealers were requested to notify their customers. Any questions were directed to Cardinal Health/VIASYS MedSystems at 800-403-3400, ext. 3473. The accounts were also requested to complete and fax back the enclosed acknowledgement form indicating if they have any remaining inventory of the recalled scissors or not.

Device

  • 모델명 / 제조번호(시리얼번호)
    catalog/reorder number 20-1225AIV, lot 32601
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    California, Illinois, Kentucky and Missouri
  • 제품 설명
    Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090 || Product is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA