Events

Device Recall Infinity Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MOOG Medical Devices Group 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
    63660
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0294-2013
  • 사례 시작날짜
    2012-11-08
  • 사례 출판 날짜
    2012-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114426
  • 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, enteral - Product Code LZH
  • 원인
    Moog medical devices group is conducting a voluntary for a limited set of serial numbers of the enteralite infinity and infinity orange small volume enteral feeding pumps because certain diodes on the pcb assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
  • 조치
    MOOG Medical Devices Group sent a Urgent Medical Device Recall letter dated November 8, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to contact Moog Medical Devices Group to discuss the process for product replacement at 1-800-970-2337, prompt #7. See Attachment A to determine if you have a serial number that is related to a suspect pump. Determine the number of affected pumps. Notify all of your affected customers of the recall and the protocol for getting a replacement pump. Provide serial numbers, number of product(s) to be returned and a shipping address for replacement product. Execute the pump replacement process discussed in the conversation with Moog Customer Advocacy. Package and return product via shipping label.

Device

Device Recall Infinity Pump
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
  • 제품 설명
    EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. || The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • 제조사 주소
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • 제조사 모회사 (2017)
    Moog Inc
  • Source
    USFDA