Events

Device Recall Jadak Barcode Scanner 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 303, 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
    73093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0814-2016
  • 사례 시작날짜
    2016-01-15
  • 사례 출판 날짜
    2016-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143056
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • 원인
    Customers reported issues when scanning medications with the scanners. when a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the pyxis product.
  • 조치
    BD sent an Urgent Medical Device Recall Notification letter dated January 15, 2015 to all affected customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete the enclosed Customer Response Card by selecting the desired deployment option and return the card to CareFusion. Customers with questions are instructed to contact the CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact CareFusion Customer Advocacy at (800) 836-7842. Customers with technical questions are instructed to contact CareFusion Technical Support at (800) 727-6102.

Device

Device Recall Jadak Barcode Scanner
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
  • 제품 설명
    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. || Product Usage: || An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • 제조사 주소
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA