Events

Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nipro Medical 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
    79834
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1876-2018
  • 사례 시작날짜
    2017-12-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163665
  • 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, blood, with and without anti-regurgitation valve - Product Code FJK
  • 원인
    There is a possibility of the heparin line is occluded.
  • 조치
    Customers were notified on approximately December 19, 2017, via letter. Instructions included to place affected lots on hold and to advise Nipro if any affected product has been further distributed. If affected product has been further distributed, Nipro advised the customer to notify those customers and have the product returned immediately. Additionally Nipro requested that they complete and return the response form to arrange for product return. For further questions, please call (305) 599-7174.

Device

Device Recall Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is ...
  • 모델명 / 제조번호(시리얼번호)
    Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : GA, NY, TN, TX.
  • 제품 설명
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. || The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • 제조사 주소
    Nipro Medical Corporation, 3150 NW 107th Ave, Doral FL 33172-2135
  • 제조사 모회사 (2017)
    Nipro Corporation
  • Source
    USFDA