Events

Device Recall DISP. HYPODERMIC NEEDLE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Medical Corporation 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
    58863
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2798-2011
  • 사례 시작날짜
    2010-06-08
  • 사례 출판 날짜
    2011-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100438
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • 원인
    Hypodermic needle packaging defect could compromise sterility. affected lot numbers are: mc1725, mc2025, mc2025.
  • 조치
    The firm, Terumo Medical Corporation sent an "URGENT PRODUCT BULLETIN: RECALL OF TERUMO PRODUCT" letter dated June 8, 2010. Consignees were contacted via telephone on June 7 thru 9, 2010 to confirm receipt of the Product Recall Bulletin. The letter describes the product, problem and the actions to be taken. The letter instructed customers to immediately discontinue use and quarantine any available stock of the listed product codes. The letter stated that distributors must not distribute any of the listed product codes, quarantine any available stock and send the recall bulletin immediately to each customer that received the recalled products to inform them of this issue. Additionally, Terumo Medical Corporation sent a "Terumo Customer Instructions for Returning Recalled Product and Customer Confirmation of Product Recall Notification" letters dated June 8, 2010 to all affected facilities. Customers were instructed to fill-out the requested information and return to Terumo Medical Corporation (TMC) Product Recall Coordinator. Consignees were contacted via telephone on June 8 and 9, 2010 to confirm receipt of the recall information and compliance with the requested action. For questions or need for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.

Device

Device Recall DISP. HYPODERMIC NEEDLE
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 431, Catalog Number 443, Catalog Number 100280
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (USA) -- AZ, CA, CO, FL, GA, IL, KS, KY, MA, MO, NC, NJ, NY, OH, PA, TN, TX, WA, UT, and VA
  • 제품 설명
    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. || Product Usage: Aspiration and injection of fluids for medical purposes.
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • 제조사 주소
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA