Events

Device Recall Infusion Pump Basal/Bolus Infusor 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
    65365
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1606-2013
  • 사례 시작날짜
    2013-06-07
  • 사례 출판 날짜
    2013-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119110
  • 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 - Product Code FRN
  • 원인
    Baxter healthcare corporation (baxter) is issuing an urgent product recall for the products listed above due to an increase in rupture complaints. baxter has implemented product and process improvements which have substantially improved product quality. complaint rates for ruptures have since decreased. baxter wants to ensure that no affected product remains in the field.
  • 조치
    An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.

Device

Device Recall Infusion Pump Basal/Bolus Infusor
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 2C1955KJP, 2C1976KJ  Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106  Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed Nationwide and in Puerto Rico.
  • 제품 설명
    Brand Name: Basal/Bolus Infusor. || Indicated for the intravenous administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA