Events

Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter 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
    80142
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2285-2018
  • 사례 시작날짜
    2018-05-09
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164671
  • 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, administration, intravascular - Product Code FPA
  • 원인
    There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
  • 조치
    B. Braun Medical Inc. sent an Urgent Voluntary Medical Device Recall Notification letter dated May 9, 2018. The letter included the following instructions for customers: 1. Review the Medical Device Recall Notification in its entirety and ensure that all users in your organization of the above mentioned product, and other concerned persons, are informed about this voluntary product recall and the affected product. Further use of this product should be discontinued immediately and affected product quarantined. 2. If you are a distributor, please immediately forward this recall notification to your customers. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Product Removal Acknowledgement" form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Removal Acknowledgement" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). It is important this form is returned, so BBMI can meet its United States Food and Drug Administration regulatory requirement. 6. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the " Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMI Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. For further questions, please call (610) 596-0500.

Device

Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0061583973
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
  • 제품 설명
    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 || The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.