Device Recall Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Site 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun Medical, 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
    51869
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1433-2009
  • 사례 시작날짜
    2009-03-27
  • 사례 출판 날짜
    2009-06-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Intravascular administration set - Product Code FPA
  • 원인
    Device defect is occlusion/no flow.
  • 조치
    An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #'61030997 with an expiration date of 12/31/2013 and Lot #'s 61031000, 61031001, 61031002, and 61031004 with an expiration date of 1/31/2014.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. || For use with Secondary Container.
  • Manufacturer

Manufacturer