Events

Device Recall Infusable and Infusa Scan Single Patient Use Pressure Infusors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 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
    58442
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2663-2011
  • 사례 시작날짜
    2011-03-04
  • 사례 출판 날짜
    2011-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99352
  • 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
    Infusor, pressure, for i.V. Bags - Product Code KZD
  • 원인
    Infusable and infusascan pressure infusors may leak and not apply desired pressure to their iv solution bag and subsequently the rate of infusion may be inadequate.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 with an attached return response form to its customers via Fed Ex. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) DO NOT use infusable or InfusaScan pressure infusors (listed lot numbers). 2) Isolate all affected product and contact Vital Signs Customer Service at +1-973-956-5300 to arrange for the return and replacement of the infusor. 3) If they have forwarded any of the affected product to any other healthcare institution, forward a copy of this letter to those institutions. 4)Return only unused product. In addition, the customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions, and to complete and return the attached confirmation form via fax to +1-973-956-5440. Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Device

Device Recall Infusable and Infusa Scan Single Patient Use Pressure Infusors
  • 모델명 / 제조번호(시리얼번호)
    IN800012; IN80048; IN80020; IN900012; IN900048; IN900020; IN950006; IN950012  Lot numbers: For the year 2009- Lot Number 2449 to Lot number 3659 F0r the year 2010 - Lot Number 0010 to Lot number 3250
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) states including: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY; and countries of: Argentina, Australia, Chile, Colombia, Canada, Denmark, Dominican Republic, Finland, Germany, Greece, Hong Kong/Macao, India, Israel, Italy, Korea, Lebanon, Lativia, Mexico, Malaysia, Nicaragua, Netherlands, New Zealand, Paraguay, Philippines, Portugal Panama, Puerto Rico, Peru, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. || A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA