Events

IFlow ONQ with SelectAFlow Pumps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 I-Flow Corporation 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
    59148
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2860-2011
  • 사례 시작날짜
    2011-04-15
  • 사례 출판 날짜
    2011-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101372
  • 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
    Infusion Pump, Elastomeric - Product Code MEB
  • 원인
    The recall was initiated because i flow became aware that a small percentage of on-q pump with select a flow may develop a minor leak with a flow rate controller. there may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.
  • 조치
    I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.

Device

IFlow ONQ with SelectAFlow Pumps
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers:  CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01.   Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831.   Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with:  98 (except 982631 and 982645),   99,   9A (except 9A2913),   9B,   9C,   01, 02, 03, 04, 05, 06, 07, 08, 09,   0A,   0B,   and 0C (except 0C2949 and 0C2950).
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
  • 제품 설명
    I-Flow ON-Q with Select-A-Flow Pumps, || Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. || It is a controller that allows the user to regulate the amount of medication that is dispensed.
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • 제조사 주소
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA