Events

BetterBladder 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
    79196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0817-2018
  • 사례 시작날짜
    2017-09-22
  • 사례 출판 날짜
    2018-03-01
  • 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=161605
  • 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
    The device is used as part of extracorporeal membrane oxygenation (ecmo) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
  • 조치
    The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to ytamari@cirtec.com as soon as possible.

Device

BetterBladder
  • 모델명 / 제조번호(시리얼번호)
    **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • 제품 설명
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
  • 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