Events

Device Recall 12F MODIFIED Tesio CATHETER SET 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Components, Inc dba MedComp 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
    79436
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1123-2018
  • 사례 시작날짜
    2018-02-23
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162321
  • 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
    Kit, repair, catheter, hemodialysis - Product Code NFK
  • 원인
    There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
  • 조치
    On February 23, 2018, Medcomp distributed Product Recall and Distribution notices to international distributors via email and to U.S. facilities via courier service on February 26, 2018. Medcomp is requesting the return of all un-used affected product. Customers should immediately examine inventory and quarantine product subject to recall. If for any reason the product was further distributed, please identify the recipients and notify them at once of this product recall. Your notification may be enhanced by including a copy of this recall notification letter. Contact your customer service representative for a Returned Goods Authorization number if necessary by calling (215) 256-4201. Complete and return the Distribution Notice via fax (215-256-9191) or email (complaints@medcompnet.com.

Device

Device Recall 12F MODIFIED Tesio CATHETER SET
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: MCBM830, MCDZ620 & MCDP130.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ireland, Israel, Italy, Netherlands, Netherlands, South Africa, Spain Sweden, Turkey & United Arab Emirates.
  • 제품 설명
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 || Product Usage: || The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • 제조사 주소
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • 제조사 모회사 (2017)
    Medical Components Inc.
  • Source
    USFDA