Events

Device Recall B. Braun addEASE Binary Connector 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
    56164
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0306-2011
  • 사례 시작날짜
    2010-06-24
  • 사례 출판 날짜
    2010-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92791
  • 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
    I.V. Fluid Transfer Set - Product Code LHI
  • 원인
    During this insertion, fragmentation of the pab container stopper may occur resulting in a small amount of visible particulates in the solution.
  • 조치
    On July 8, 2010 B Braun sent an Urgent - Medical Device Recall letter, dated June 28, 2010, to consignees informing them of the recall and that further distribution or use of the affected product should cease immediately. The attached "Product Removal Acknowledgement" form should be used to record the number of units and full-unopened cases that customers have in their inventory. The completed form should be returned via mail or fax within 2 weeks of receipt. If consignees have any full or partial cases of these affected products, they are to please call the Customer Support Department at (800) 227-2862 to arrange for return. Canadian customers may call (800) 624-2920. International customers may call (610) 691-5400. A Customer Support Representative will provide consignees with instructions for handling the affected product. The firm will arrange for unopened cases to be returned to B. Braun Medical, Inc. for proper disposal. Individual units (out of shipping cases) may be destroyed at the consignees facility. Consignees were informed that B. Braun is currently working to resolve this issue and provide an acceptable alternative to the market. They expect this product to be available in August 2010. In the interim, B. Braun PAB containers can continue to be used safely with a standard syringe and needle in accordance with the Direction for Use. If customers have additional questions regarding with a matter, they are to call B. Braun Customer Support Department at the number listed above. Should consignees identify product where this condition has occurred, consignees were asked to report it promptly to B. Braun Medical Inc. by contacting the B. Braun Clinical and Technical support at 1-800-854-6851.

Device

Device Recall B. Braun addEASE Binary Connector
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  60928513, 60936541, 60936543, 60942059, 60950900, 60953588, 60969534, 60972173, 60973280, 60983742, 60997643, 61003958, 61017469, 61027183, 61027186, 61031167, 61031168, 61042196, 61045157, 61056656, 61057867, 61058745, 61073202, 61078826, 61085625, 61096650, 61102775, 00VL907673, 00VL907677, 00VL912573, 00VL927133, 00VL927134, and 00VL927135.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) || Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
  • Manufacturer
    B. Braun Medical Inc

Manufacturer

B. Braun Medical Inc
  • 제조사 주소
    B. Braun Medical Inc, 2525 McGaw Ave, Irvine CA 92614-5841
  • Source
    USFDA