Events

NonVented Dispensing Pin 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
    73986
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1906-2016
  • 사례 시작날짜
    2016-04-14
  • 사례 출판 날짜
    2016-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145828
  • 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
    Bbmi recently identified a potential for a tear in the outer blister packaging on a limited number of units. the tears have been identified in the blister package paper, where the unit label writing is located.
  • 조치
    B. Braun notified customers via letter to inform them of the reason for the recall, the risks and affected lots involved were identified and customers were asked to discontinue use of the product and complete the Product Removal Acknowledgement form and return to B. Braun Medical Inc. Quality Assurance department by faxing it to (610)849-1197 or e-mail to: PA_QualityAssurance.BBMUS_Service@bbraun.com and a BBMI Customer Support Representative will contact the consignee to provide instructions for handling the affected product and arrange for its return to BBMI.

Device

NonVented Dispensing Pin
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092 Product Catalog Number: 412023 and 412027
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico
  • 제품 설명
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve || Product Usage: || Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.