Events

Device Recall Nutrisafe 2 35 mL Syringe for Safety Connection 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
    78951
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0678-2018
  • 사례 시작날짜
    2017-07-24
  • 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=160954
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our tyvek supplier has notified vygon of issues with their product, specifically the tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. this potential lack of adhesive may affect the sterility of the product.
  • 조치
    Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.

Device

Device Recall Nutrisafe 2 35 mL Syringe for Safety Connection

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