Events

Device Recall Beacon Tip Torcon NB Advantage Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cook 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
    71692
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2317-2015
  • 사례 시작날짜
    2015-07-02
  • 사례 출판 날짜
    2015-08-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138757
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • 원인
    Reports of catheter tip splits and or separation. loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
  • 조치
    Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.

Device

Device Recall Beacon Tip Torcon NB Advantage Catheter
  • 모델명 / 제조번호(시리얼번호)
    All Lots of following Product numbers: HNBR4.0-35-100-P-NS-0, HNBR4.0-35-100-P-NS-C1, HNBR4.0-35-100-P-NS-C2, HNBR4.0-35-100-P-NS-CANADA-041480, HNBR4.0-35-100-P-NS-DAV, HNBR4.0-35-100-P-NS-H1, HNBR4.0-35-100-P-NS-JB1,  HNBR4.0-35-100-P-NS-JB2, HNBR4.0-35-100-P-NS-JB3,  HNBR4.0-35-100-P-NS-JIM,  HNBR4.0-35-100-P-NS-KMP,  HNBR4.0-35-100-P-NS-MPA, HNBR4.0-35-100-P-NS-O1,  HNBR4.0-35-100-P-NS-SIM1,  HNBR4.0-35-100-P-NS-SIM2,  HNBR4.0-35-100-P-NS-SIM3, HNBR4.0-35-100-P-NS-VERT,  HNBR4.0-35-100-P-NS-VTK,  HNBR4.0-35-100-P-NS-WNBG,  HNBR4.0-35-125-P-NS-0, HNBR4.0-35-125-P-NS-DAV,  HNBR4.0-35-125-P-NS-H1,  HNBR4.0-35-125-P-NS-JB1,  HNBR4.0-35-125-P-NS-JB2, HNBR4.0-35-125-P-NS-MPA,  HNBR4.0-35-125-P-NS-SIM2,  HNBR4.0-35-125-P-NS-VERT,  HNBR4.0-35-125-P-NS-VTK, HNBR4.0-35-125-P-NS-WNBG,  HNBR4.0-35-40-P-NS-KMP,  HNBR4.0-35-65-P-NS-0,  HNBR4.0-35-65-P-NS-C1, HNBR4.0-35-65-P-NS-C2,  HNBR4.0-35-65-P-NS-C3,  HNBR4.0-35-65-P-NS-DAV,  HNBR4.0-35-65-P-NS-H1,  HNBR4.0-35-65-P-NS-JB1, HNBR4.0-35-65-P-NS-KMP,  HNBR4.0-35-65-P-NS-MPA,  HNBR4.0-35-65-P-NS-RC1,  HNBR4.0-35-65-P-NS-RC2, HNBR4.0-35-65-P-NS-RDC,  HNBR4.0-35-65-P-NS-RIM,  HNBR4.0-35-65-P-NS-SIM1,  HNBR4.0-35-65-P-NS-SIM2, HNBR4.0-35-80-P-NS-C1,  HNBR4.0-35-80-P-NS-C2,  HNBR4.0-35-80-P-NS-JL2,  HNBR4.0-35-80-P-NS-JL2.5, HNBR4.0-35-80-P-NS-JL3,  HNBR4.0-35-80-P-NS-JR1,  HNBR4.0-35-80-P-NS-JR2,  HNBR4.0-35-80-P-NS-JR3.5, HNBR4.0-35-80-P-NS-RH,  HNBR4.0-35-80-P-NS-RLG,  HNBR4.0-35-80-P-NS-VS,  HNBR4.0-35-80-P-NS-VS1, HNBR4.0-35-80-P-NS-VS2,  HNBR4.0-35-80-P-NS-VS3,  HNBR4.0-NT-100-P-NS-H1,  HNBR4.0-NT-80-P-NS-RC1, HNBR4.0-NT-80-P-NS-RIM,  HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0,  HNBR4.1-35-100-P-NS-C1, HNBR4.1-35-100-P-NS-C2,  HNBR4.1-35-100-P-NS-DAV,  HNBR4.1-35-100-P-NS-H1,  HNBR4.1-35-100-P-NS-JB1, HNBR4.1-35-100-P-NS-JB2,  HNBR4.1-35-100-P-NS-JB3,  HNBR4.1-35-100-P-NS-KMP,  HNBR4.1-35-100-P-NS-MPA, HNBR4.1-35-100-P-NS-O1,  HNBR4.1-35-100-P-NS-SIM1,  HNBR4.1-35-100-P-NS-SIM2,  HNBR4.1-35-100-P-NS-SIM3, HNBR4.1-35-100-P-NS-VERT,  HNBR4.1-35-100-P-NS-WNBG,  HNBR4.1-35-110-P-NS-JB1,  HNBR4.1-35-110-P-NS-JB2, HNBR4.1-35-110-P-NS-WNBG,  HNBR4.1-35-120-P-NS-JB2,  HNBR4.1-35-130-P-NS-DAV-T,  HNBR4.1-35-40-P-NS-KMP, HNBR4.1-35-65-P-NS-C1,  HNBR4.1-35-65-P-NS-C2,  HNBR4.1-35-65-P-NS-DAV,  HNBR4.1-35-65-P-NS-H1,  HNBR4.1-35-65-P-NS-JB1, HNBR4.1-35-65-P-NS-KMP,  HNBR4.1-35-65-P-NS-LEV1,  HNBR4.1-35-65-P-NS-MPA,  HNBR4.1-35-65-P-NS-RC1, HNBR4.1-35-65-P-NS-RC2,  HNBR4.1-35-65-P-NS-RDC,  HNBR4.1-35-65-P-NS-RIM,  HNBR4.1-35-65-P-NS-SHK1.0, HNBR4.1-35-65-P-NS-SIM1,  HNBR4.1-35-75-P-NS-CHG-D,  HNBR4.1-35-80-P-NS-C1,  HNBR4.1-35-80-P-NS-C2, HNBR4.1-35-80-P-NS-JL2,  HNBR4.1-35-80-P-NS-JL2.5,  HNBR4.1-35-80-P-NS-JL3,  HNBR4.1-35-80-P-NS-JR1, HNBR4.1-35-80-P-NS-JR2,  HNBR4.1-35-80-P-NS-JR3.5,  HNBR4.1-35-80-P-NS-RC1,  HNBR4.1-35-80-P-NS-RH, HNBR4.1-35-80-P-NS-RLG,  HNBR4.1-35-80-P-NS-VS,  HNBR4.1-35-80-P-NS-VS2,  HNBR4.1-NT-100-P-NS-H1, HNBR4.1-NT-80-P-NS-C1,  HNBR4.1-NT-80-P-NS-RC1,  HNBR4.1-NT-80-P-NS-RH,  HNBR4.1-NT-80-P-NS-RIM, HNBR4.1-NT-80-P-NS-RLG,  HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • 제조사 주소
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • 제조사 모회사 (2017)
    Cook Group Incorporated
  • Source
    USFDA