Events

Device Recall Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check 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
    53955
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0703-2010
  • 사례 시작날짜
    2009-11-24
  • 사례 출판 날짜
    2010-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87424
  • 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
    System error 9 alarms. a system error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). this alarm is generated during the pumps initiation sequence and will not allow the set to be used. this requires a new set to be obtained, thus creating a potential for delay in therapy.
  • 조치
    The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction 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. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.

Device

Device Recall Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pres...
  • 모델명 / 제조번호(시리얼번호)
    Product Code NF3140. Lot numbers: 61040801 exp 2/28/2012, 61040802 exp 2/28/2012, 61040803 exp 2/28/2012, 61040804 exp 3/30/2012, 61040805 exp 3/30/2012, 61040806 exp 3/30/2012, 61044303 exp 3/30/2012, 61044304 exp 4/30/2012, 61049787 exp 4/30/2012, 61049790 exp 4/30/2012, 61049793 exp 4/30/2012, 61049794 exp 4/30/2012, 61049795 exp 5/31/2012, 61049796 exp 5/31/2012, 61049797 exp 5/31/2012, 61049798 exp 5/31/2012, 61049799 exp 5/31/2012, 61049800 exp 5/31/2012, 61049801 exp 5/31/2012, 61057015 exp 6/30/2012, 61057016 exp 6/30/2012, 61057017 exp 6/30/2012, 61057018 exp 6/30/2012, 61057019 exp 6/30/2012, 61057200 exp 6/30/2012, 61057201 exp 7/30/2012, 61072172 exp 7/30/2012, 61072173 exp 7/30/2012, 61072174 exp 7/30/2012, and 61072175 exp 7/30/2012.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
  • 제품 설명
    Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.