Events

CollectEVAC 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Civco Medical Instruments 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
    68951
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2558-2014
  • 사례 시작날짜
    2014-08-01
  • 사례 출판 날짜
    2014-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129097
  • 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
    Evacuator, gastro-urology - Product Code KQT
  • 원인
    A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
  • 조치
    Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.

Device

CollectEVAC
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: M431760, M431710, M426580, M430200, M423010
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
  • 제품 설명
    CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. || The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • 제조사 주소
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • 제조사 모회사 (2017)
    Roper Technologies Inc
  • Source
    USFDA