Events

Device Recall Bard CritiCore 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 C.R. Bard, Inc., Urological Division 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
    57291
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0719-2011
  • 사례 시작날짜
    2010-11-17
  • 사례 출판 날짜
    2010-12-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95763
  • 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
    Electrical Urinometer - Product Code EXS
  • 원인
    Error can occur in the reading of the present interval output (pio) reading when the device is subjected to bumping or forceful replacement of the fluid container.
  • 조치
    Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.

Device

Device Recall Bard CritiCore
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 000002N, Serial numbers: DYTA0001, DYTA0002, DYTA0003, DYTA0007, DYTA0008, DYTA0011, DYTA0012, DYTA0015, DYTA0016, DYTA0017, DYTA0018, DYTA0019, DYTA0020, DYTA0021, DYTA0022, DYTA0024, DYTA0025, DYTA0027, DYTA0028, DYTA0029, DYTA0030, DYTA0031, DYTA0032, DYTA0033, DYTA0034, DYTA0036, DYTA0037, DYTA0038, DYTA0039, DYTA0040, DYTA0041, DYTA0042, DYTA0043, DYTA0044, DYTA0045, DYTA0046, DYTA0047, DYTA0049, DYTA0050, DYTA0051, DYTA0052, DYTA0053, DYTA0054, DYTA0056, DYTA0057, DYTA0058, DYTA0059, DYTA0060, DYTB0001, DYTB0003, DYTB0004, DYTB0005, DYTB0009, DYTB0010, DYTB0011, DYTB0012, DYTB0013, DYTB0015, DYTB0016, DYTB0020, DYTB0021, DYTB0022, DYTB0023, DYTB0024, DYTB0025, DYTB0026, DYTB0027, DYTB0029, DYTB0030, DYTB0031, DYTB0033, DYTB0038, DYTC0001, DYTC0004, DYTC0010, DYTC0011, DYTC0016, DYTC0017, DYTC0018, DYTC0019, DYTC0020, DYTC0021, DYTC0022, DYTC0024, DYTC0025, DYTC0026, DYTC0027, DYTC0029, DYTC0030, DYTC0031, DYTC0032, DYTC0033, DYTC0034, DYTC0035, DYTC0036, DYTC0037, DYTC0038, DYTC0039, DYTC0040, DYUC0001, DYUC0002, DYUC0004, DYUC0005, DYUC0009, DYUC0012, DYUC0014, DYUC0015, DYUC0016, DYUC0017, DYUC0018, DYUC0019, DYUC0020, DYUD0001, DYUD0002, DYUD0003, DYUD0004, DYUD0005, DYUD0006, DYUD0007, DYUD0008, DYUD0009, DYUD0011, DYUD0012, DYUD0013, DYUD0014, DYUD0015, DYUD0016, DYUD0017, DYUD0019, DYUD0020, DYUD0021, DYUD0022, DYUD0023, DYUD0026, DYUD0027, DYUD0028, DYUD0029, DYUD0030, DYUD0031, DYUD0033, DYUD0034, DYUD0035, DYUD0036, DYUD0037, DYUD0038, DYUD0039, DYUD0042, DYUD0043, DYUD0045, DYUD0046, DYUD0047, DYUD0048, DYUD0049, DYUD0050, DYUD0052, DYUD0053, DYUD0055, DYUD0057, DYUD0058, DYUD0059, DYUE0002, DYUE0007, DYUE0008, DYUE0011, and DYUE0014.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- U.S., Netherlands, and Japan.
  • 제품 설명
    Bard¿ CritiCore¿ Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. || Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • 제조사 주소
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Source
    USFDA