B. Braun 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 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
    65356
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0425-2014
  • 사례 시작날짜
    2013-04-04
  • 사례 출판 날짜
    2013-11-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-08-26
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • 원인
    Possible solution leakage at the interface of the addease(tm) binary connector (product codes bc2000 and bc1300) and the pab(r) bag. based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addease(tm) binary connector, which pierces the pab(r) bag stopper to access the solution. the misaligned cannula may result i.
  • 조치
    B Braun sent an Urgent - Medical Device Removal Notification letter dated April 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by he customer. Customers were instructed to review the Product Recall Notification in its entirety and ensure that all users in their organization are informed about this voluntary product recall. Determine their current inventory of the affected lots within their distribution center. Contact their customers that have received the affected lots and inform them of this voluntary product recall. Combine both their inventory, and the inventory reported by their customers, and utilize their specific "Product Removal Acknowledgement" form to record the total number of individual units (within partial cases) and the number of full-unopened cases. If no inventory remaining enter zero (0). Return the completed Acknowledgement Form to BBMI Quality Assurance in the self addressed envelope or fax to 610-849-1197. Customers should call Customer Support Department at 800-227-2862 to arrange for eturn and replacement product or for questions. For questions regarding this recall call 800-227-2862.

Device

  • 모델명 / 제조번호(시리얼번호)
    Material BC1300, Lot number 61286479.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 || Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
  • Manufacturer

Manufacturer