Events

Device Recall Baxter Single Day Infusor 2 mL/h System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    58181
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2146-2011
  • 사례 시작날짜
    2011-03-15
  • 사례 출판 날짜
    2011-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98608
  • 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, elastomeric - Product Code MEB
  • 원인
    Some of the single day infusor system 2 ml/h have a foil over-pouch that was incorrectly labeled as the half day infusor system 5 ml/h, product code 2c1073kjp, lot 10h054.
  • 조치
    Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Single Day Infusor 2 mL/h System
  • 모델명 / 제조번호(시리얼번호)
    product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL and the countries of Mexico and Spain
  • 제품 설명
    Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP || The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA