Events

Device Recall 24K Arthroscopy Outflow/Suction Tubing Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    63107
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2469-2012
  • 사례 시작날짜
    2011-07-01
  • 사례 출판 날짜
    2012-09-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112562
  • 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, irrigation - Product Code GBX
  • 원인
    Conmed linvatec recalled their 24k arthroscopy outflow/suction tubing set (product number 24k100)because there is a possibility that the product may have a breach in the tyvek seal that could potentially compromise the sterility of the contents.
  • 조치
    ConMed Linvatec sent a Urgent Medical Device Recall Notification via FedEx to all affected customers. This notice should be received July 5, 2011. The letter identified the product the problem and the action needed to be taken by the customer. All returned product under this removal action will be identified, segregated, and quarantined per ConMed Utica, N.Y. procedures. Returned product will be dispositioned in accordance with ConMed Utica, N.Y. procedures. This can include repackaged and resterilization with new lot number or product scrap. ConMed Utica, N.Y. will maintain control of all individual lot numbers returned and dispositioned. Firm is striving for 1005 effectiveness. If a Reply form is not received within approximately 30 days of the first mailing, ConMed Linvatec will make two additional contacts by mail approximately 30-35 days apart. Should you have any additional questions please contact our Customer Service at 800-237-0169 or fax at 727-319-5701.

Device

Device Recall 24K Arthroscopy Outflow/Suction Tubing Set
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
  • 제품 설명
    Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** || This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA