Events

Device Recall Graseby 3300 Pump and Graseby 3000 Seri8es Pump Accessories 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD 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
    78943
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0497-2018
  • 사례 시작날짜
    2017-08-24
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160935
  • 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
    Pump, infusion, pca - Product Code MEA
  • 원인
    In certain cases, the lock and key supplied with graseby 3300 pumps and accessories does not match the standard graseby 3300 key.
  • 조치
    Notification was sent to customers on August 24, 2017. Included with the Product Safety & Recall Notification, Instructions to Customers and the Recall response Form. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths. For further questions, please call (763) 383-3072.

Device

Device Recall Graseby 3300 Pump and Graseby 3000 Seri8es Pump Accessories
  • 모델명 / 제조번호(시리얼번호)
    Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland
  • 제품 설명
    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories || Patient controlled syringe pump. Use for Infusion
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • 제조사 주소
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA