Events

SlipCath Beacon Tip 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
    74010
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2614-2016
  • 사례 시작날짜
    2016-04-15
  • 사례 출판 날짜
    2016-08-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145895
  • 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
    Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
  • 조치
    Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, 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. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.

Device

SlipCath Beacon Tip Catheter
  • 모델명 / 제조번호(시리얼번호)
    All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5  Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G11993 SCBR5.0-38-65-P-NS-0 G12009 SCBR5.0-38-65-P-NS-C1 G12003 SCBR5.0-38-65-P-NS-C2 G11994 SCBR5.0-38-65-P-NS-C3 G12004 SCBR5.0-38-65-P-NS-DAV G23688 SCBR5.0-38-65-P-NS-H1 G13319 SCBR5.0-38-65-P-NS-KMP G12156 SCBR5.0-38-65-P-NS-LEV1 G12798 SCBR5.0-38-65-P-NS-MPA G23689 SCBR5.0-38-65-P-NS-RC2 G13272 SCBR5.0-38-65-P-NS-RDC G13092 SCBR5.0-38-65-P-NS-RIM G11995 SCBR5.0-38-65-P-NS-SIM1 G12716 SCBR5.0-38-65-P-NS-SIM2 G23691 SCBR5.0-38-65-P-NS-TC G36320 SCBR5.0-38-65-P-NS-TC-BNK G36322 SCBR5.0-38-65-P-NS-TEGT G12179 SCBR5.0-38-80-P-NS-C2 G12006 SCBR5.0-38-80-P-NS-MPA G23692 SCBR5.0-38-80-P-NS-RH G36214 SCBR5.0-38-80-P-NS-VS G13431 SCBR5.0-38-80-P-NS-VS1 G13432 SCBR5.0-38-80-P-NS-VS2 G13433 SCBR5.0-38-80-P-NS-VS3 G13434 SCBR5.5-35-60-P-NS-PATEL G51570 SCBR6.5-35-60-P-NS-PATEL G51571
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
  • 제품 설명
    Slip-Cath¿ Beacon¿ Tip Catheter || Catheter, Intravascular, Diagnostic || The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
  • 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