Device Recall CheckFlo Hemostasis Assembly 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
    76360
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1389-2017
  • 사례 시작날짜
    2017-02-01
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Accessories, catheter - Product Code KGZ
  • 원인
    Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
  • 조치
    Cook Inc. is initiating a voluntary recall of multiple products following the identification of an increase in reports of blood loss associated with devices using a specific hemostatic valve design referred to as the blue valve or polyisoprene valve. Potential adverse events that may occur if these devices were used in the arterial system (Flexor Radial Access Sets) include delay in procedure and blood loss. If devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. The firm is distributing notices via mail courier on 02/01/2017. Customers are being instructed to share the recall notice with appropriate personnel, including down to the user level, within the customer's organization or to any organization where the potentially affected devices have been transferred. 1. Examine inventory immediately to determine if customers have affected product and quarantine affected product(s). 2. Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Returned un-affected product will not be credited. 3. Even if customers do not have affected product on hand, customers must still complete the Acknowledgement and Receipt Form and return via fax 812.339.7316 or email to Fieldactionsna@cookmedical.com. 4. Report adverse events to COOK Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Effectiveness checks of this recall will be done by response form mailed. All recalled products will be destroyed at the regional distribution warehouses. A cer

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog Identifier: CFM-200  Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom VA/DOD: Yes
  • 제품 설명
    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
  • Manufacturer

Manufacturer

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