Device Recall Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock 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-0706-2010
  • 사례 시작날짜
    2009-11-24
  • 사례 출판 날짜
    2010-01-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-02-14
  • 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
    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

  • 모델명 / 제조번호(시리얼번호)
    Product Code SS3140. Lot numbers:61033501 exp 4/30/2012, 61033502 exp 6/30/2012, 61067405 exp 7/30/2012, and 61067406 exp 7/31/2012.
  • 의료기기 분류등급
  • 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, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock Connector 134 in
  • Manufacturer

Manufacturer