Events

Device Recall Better Baldder 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Circulatory Technology 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
    74614
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0057-2017
  • 사례 시작날짜
    2016-07-01
  • 사례 출판 날짜
    2016-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148047
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • 원인
    Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
  • 조치
    The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to ytamari@cirtec.com. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.

Device

Device Recall Better Baldder
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: R19229, 015323, 014882, 014602 & 014601
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
  • 제품 설명
    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, || Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Manufacturer
    Circulatory Technology Inc

Manufacturer

Circulatory Technology Inc
  • 제조사 주소
    Circulatory Technology Inc, 21 Singworth St, Oyster Bay NY 11771-3703
  • 제조사 모회사 (2017)
    Circulatory Technology Inc
  • Source
    USFDA