Events

Vygon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vygon MFG, Inc., dba/ Churchill 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
    79318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0933-2018
  • 사례 시작날짜
    2017-10-03
  • 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=161870
  • 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
    I.V. start kit - Product Code LRS
  • 원인
    The iodine prep pads within the vygon iv start convenience kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. all kits containing the affected pads were recalled.
  • 조치
    Vygon sent an Urgent Medical Device Recall letter dated October 3, 2017. Customers requested to check stock and quarantine affected devices and to complete Recall Acknowledgement and Inventory Return Form. Customers instructed to fax or email the form to Vygon including customer contact info. Vygon will contact the customer and issue a Return Merchandise Authorization Number. Distributors instructed to communicate recall to customers who received affected product and provide them copy of the recall notification. Returned products were received in Lansdale, PA warehouse location and placed into quarantine. For further questions, please call Customer Service at (800) 473-5414.

Device

Vygon
  • 모델명 / 제조번호(시리얼번호)
    AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution.
  • 제품 설명
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. || Kit used when administering IV during emergency.
  • Manufacturer
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Manufacturer

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
  • 제조사 주소
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., 87 Venture Dr, Dover NH 03820-5914
  • 제조사 모회사 (2017)
    Soc Part Financiere Pierre Simonet
  • Source
    USFDA