Events

Device Recall CareFusion, SnowdenPencer, DiamondFlex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carefusion 2200 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
    74465
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2212-2016
  • 사례 시작날짜
    2016-07-01
  • 사례 출판 날짜
    2016-07-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147639
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • 원인
    Bd, formerly carefusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. if this failure were to occur while in use in a procedure it has the potential to damages tissue or organs.
  • 조치
    BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.

Device

Device Recall CareFusion, SnowdenPencer, DiamondFlex
  • 모델명 / 제조번호(시리얼번호)
    Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
  • 제품 설명
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. || Designed to retract or elevate organs and tissue to provide better visualization access.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc