Events

Device Recall Coronary Control Syringe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merit Medical Systems, Inc. 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
    49002
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2366-2008
  • 사례 시작날짜
    2008-07-09
  • 사례 출판 날짜
    2008-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72502
  • 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
    Syringe - Product Code FMF
  • 원인
    Control syringes may be non-sterile due to holes in the packaging.
  • 조치
    Urgent Product Recall letters dated 07/09/08, were faxed on 07/09/2008 to consignees/sales reps. The letter instructed consignees/sales reps to contact their customers by phone or visit to provide recall information and instructions. Customers were told to immediately discontinue use and to quarantine all affected products. A Product Retrieval Form was provided that was to be signed by the site representative. Contact Merit Medical at 1-801-208-4408 for assistance.

Device

Device Recall Coronary Control Syringe
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: F621152
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, and WA. Foreign distribution to Japan.
  • 제품 설명
    10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. The product is used for injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • 제조사 주소
    Merit Medical Systems, Inc., 1600 Merit Pkwy, South Jordan UT 84095
  • 제조사 모회사 (2017)
    Merit Medical Systems Inc
  • Source
    USFDA