Events

Device Recall SIMPULSE SOLO SUCTION IRRIGATOR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Davol, Inc., Sub. C. R. Bard, 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
    52768
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1948-2009
  • 사례 시작날짜
    2009-07-30
  • 사례 출판 날짜
    2009-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83936
  • 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
    Holder, needle, gastroenterologic - Product Code FHQ
  • 원인
    Product sterility may be compromised due to lack of package integrity.
  • 조치
    Davol issued a Recall Letter dated July 30, 2009 requesting user facilities examine inventory and immediately discontinue use of any product from the affected lot and return it to Davol. Direct questions about the recall to Davol, Inc., Sub. C. R. Bard, Inc. by calling 1-401-463-7000.

Device

Device Recall SIMPULSE SOLO SUCTION IRRIGATOR
  • 모델명 / 제조번호(시리얼번호)
    Lot Number JUSHF083.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    BARD¿ Simpulse" SOLO System with Soft Splash Shield Tip || Product Code: 0067590. || The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • 제조사 주소
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA