Events

Device Recall Baxa EVA TPN bags 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxa 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
    52120
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1420-2012
  • 사례 시작날짜
    2009-05-08
  • 사례 출판 날짜
    2012-04-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82144
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • 원인
    Spike port flor eva tpn bags contains low levels of dehp which could leach out.
  • 조치
    Baxa sent a Customer Notice letter dated May 8, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Current Baxa product is mislabeled as non-DEHP but this does not present a risk to patients. Baxa is committed to providing products that are non-DEHP. We are working with our supplier to replace the spike port with a non-DEHP as soon as possible. In the meantime, product labeling will be updated to reflect this finding. For further questions please call (303) 690-4204.

Device

Device Recall Baxa EVA TPN bags
  • 모델명 / 제조번호(시리얼번호)
    Model 137, Size 250 ml, Cat. No. H938 137 3 Model 138, Size 500 ml, Cat No. H938 138 3  Model 139, Size 1000 ml, Cat No. H938 139 3 Model 140, Size 2000 ml,Cat. No. H938 140 3 Model 141, Size 3000 ml, Cat. No. H938 141 3 Model 142, Size 4000 ml, Cat. No. H938 142 3 Model 143, Size 5000 ml, Cat. No. H938 143 3 Model 341, Size 500/3000 ml, Cat No. H938 341 3
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide)
  • 제품 설명
    Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • 제조사 주소
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA