Events

Belzer UW Cold Storage Solution 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Preservation Solutions 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
    56913
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0427-2011
  • 사례 출판 날짜
    2010-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94913
  • 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
    System, perfusion, kidney - Product Code KDN
  • 원인
    Mislabeled volume - 2 liter bags of belzer uw cold storage solution were labeled as 1 liter.
  • 조치
    Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..

Device

Belzer UW Cold Storage Solution
  • 모델명 / 제조번호(시리얼번호)
    Batch # Bt017170, Lot# BC071710
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution - in US to the states of CA, MO, and PA.
  • 제품 설명
    Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
  • Manufacturer
    Preservation Solutions Inc

Manufacturer

Preservation Solutions Inc
  • 제조사 주소
    Preservation Solutions Inc, 980 Proctor Dr., P.O. Box 937, Elkhorn WI 53121-0937
  • Source
    USFDA