Wilson Cook Multiple Band Ligator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cook Endoscopy 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
    56808
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0092-2011
  • 사례 시작날짜
    2010-09-03
  • 사례 출판 날짜
    2010-10-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-03-31
  • 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
    Ligator, esphageal - Product Code MND
  • 원인
    A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. this could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.
  • 조치
    COOK Endoscopy sent an URGENT: PRODUCT RECALL dated September 3, 2010, via USPS Certified Mail and by email to all consignees. The letter identified the products, the problem, and the action to be taken by the consignees. All consignees were instructed to quarantine any affected product and return them to Cook Medical. Distributors were instructed to contact their customers and coordinate the return of the affected product to Cook Medical. Within 2 weeks of the initial recall notification, Level B effectiveness checks (40% of the total number of consignees) will be conducted. These customers will receive a recall effectiveness survey. All non-responding consignees will receive a total of 3 recall notifications (2 follow-up requests for a response in addition to the initial recall notification. Monthly status reports regarding this recall will be provided to FDA. All devices returned as part of this recall will be destroyed by the recalling firm upon receipt of authorization to do so by FDA. Forty percent (40%) of total customers affected received a second notice on 9/17/2010 as part of the effectiveness checks. As of 9/21/2010, 38% of all affected customers have responded. For questions contact the Customer Relations Department at CustomerRelationsNA@cookmedical.com or call 1-800-457-4500, press 4 then enter extension 2146.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Order Number: MBL-10, Lot No. W2758471, W2758472, W2758474, W2760365, 22760366, 22760380, W2763652, W2764330, W2764331, W2764332, W2772073, W2772074 and W2772075; MBL-10-F, Lot No. W2763624, W2763626, W2763634, W2767450, W2768607, W2768615, W2768616, W2768617, W2770052, W2773557 and W2773558; MBL-10-I, Lot No. W2767442; MBL-10-XS, Lot No. W2787044, W2795540 and W2796313.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV, and WY; and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela.
  • 제품 설명
    Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 || This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA