Events

Device Recall Heparin I.V. Flush Syringe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medefil Incorporated 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
    67562
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1149-2014
  • 사례 시작날짜
    2014-02-19
  • 사례 출판 날짜
    2014-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125720
  • 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
    Heparin, vascular access flush - Product Code NZW
  • 원인
    The bar code that is printed on the master carton label does not correspond to the product code fully displayed on the master carton label. the non-matching information can only be detected by using a bar code reader. the defective bar codes will be read as product no. mih-3335 ( heparin i.V. flush syringe 100 units/ml; 5 ml fill in 12 ml syringe) whereas this product is actually product no. mih-3333 (heparin i.V. flush syringe 100 units/ml; 3 ml fill in 12 ml syringe).
  • 조치
    URGENT MEDICAL DEVICE CORRECTION letters dated February 19, 2014 were sent to all direct accounts. The letters included instructions to: quarantine the recalled products; and,complete and return the attached customer response form (via Fax to 630-681-9100 or via mail to Medefil Inc., 250 Windy Point Drive, Glendale Heights, IL 60139) so that the correct number of replacement labels can be sent from Medefil.

Device

Device Recall Heparin I.V. Flush Syringe
  • 모델명 / 제조번호(시리얼번호)
    Product Number: MIH-3333;  NDC Number: 64253-333-33;  Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.
  • 제품 설명
    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
  • Manufacturer
    Medefil Incorporated

Manufacturer

Medefil Incorporated
  • 제조사 주소
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • 제조사 모회사 (2017)
    Medefil Inc.
  • Source
    USFDA