Events

Device Recall Nipro 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
    65274
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1834-2014
  • 사례 시작날짜
    2013-05-04
  • 사례 출판 날짜
    2014-06-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118426
  • 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
    Catheter,intravascular,therapeutic,short-term less than - Product Code FOZ
  • 원인
    There is a possibility of a crack in the cp luer connector. the position of the crack is at the connection site of the cp luer connector and the tubing. the crack could cause or contribute to leakage of fluids.
  • 조치
    Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621. Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.

Device

Device Recall Nipro
  • 모델명 / 제조번호(시리얼번호)
    Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
  • 제품 설명
    NIPRO Safe Touch Safety Scalp Vein Set
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • 제조사 주소
    Nipro Medical Corporation, 3150 Nw 107th Ave, Miami FL 33172
  • 제조사 모회사 (2017)
    Nipro Corporation
  • Source
    USFDA