Device Recall B. Braun 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 B. Braun Medical, Inc. 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
    67172
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0921-2014
  • 사례 시작날짜
    2013-12-13
  • 사례 출판 날짜
    2014-02-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Internal testing of two lots of the accuflo ct-2000-100 elastomeric infusion pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.
  • 조치
    B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization and any consignees your organization may have are informed of this recall. If you are a distributor, please forward this recall notice to any customers who are in receipt of the impacted product. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Recall Acknowledgement" form record the number of full cases and individual units (for any loose units or partial cases) in your possession. If you have no inventory, please indicate that you have zero (0) inventory on the "Recall Acknowledgement" form. 5. Return the completed "Recall Acknowledgement" form to B. Braun Medical Inc. Quality Assurance who will administer the recall on behalf of B. Braun Melsungen AG. The form must be e-mailed to PA_QualityAssurance.BBMUS.Service@bbraun.com or faxed to (610) 849-1197 within two (2) weeks of receipt even it the inventory in your possession is zero. 6. Instructions for Credit, Replacement, Et Return: a.If you have purchased the product from a third-party and have any full cases, partial cases, or unused individual pieces in your possession please contact the seller to obtain instructions for handling these units. b.If you have purchased the product directly from B. Braun Medical Inc. and have any full cases, partial cases, or unused individual pieces of these affected products, ple

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution one importer/wholesale distributor in MO.
  • 제품 설명
    B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML || Generally used for delivery of antibiotic and local anesthesia medications.
  • Manufacturer

Manufacturer