Events

Device Recall G2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Peripheral Vascular 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
    37021
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0393-2007
  • 사례 시작날짜
    2006-12-20
  • 사례 출판 날짜
    2007-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49776
  • 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
    embolism filter - Product Code DTK
  • 원인
    This action is being taken because bpv has recently received three complaints for the device that involve reports of introducer sheath tip damage. the damage may result in loss of tip integrity.
  • 조치
    Recall letters were sent to all consignees via Federal Express overnight delivery with signature receipt required on December 20, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV). Customers will be asked to immediately remove product from inventory and isolated from use and contact BARD for return authorization. All returned product will be destroyed.

Device

Device Recall G2
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers:  GFPK4733, GFPK4734, GFPL4229, GFPL4230, GFPL4231, GFQA1497, GFQA1498, GFQA1499, GFQA1500, GFQA1501, GFQA1502, GFQA1503, GFQA1504, GFQA1505, GFQA1506, GFQA2794, GFQA2795, GFQA2796, GFQA2797, GFQA2798, GFQA2994, GFQA2995, GFQA2996, GFQA2997, GFQA2998, GFQA2999, GFQB1909, GFQB1910, GFQB1911, GFQB1912, GFQB1913, GFQB1914, GFQB1915, GFQB1916, GFQC1489, GFQC1490, GFQC1491, GFQC3088, GFQC3089, GFQC3090, GFQD0153, GFQD0154, GFQD0155, GFQD0156, GFQD0157, GFQD0158, GFQD0159, GFQD0160, GFQD2046, GFQD2047, GFQD2048, GFQD3730, GFQD3731, GFQD3732, GFQD3733, GFQD3734, GFQD3735, GFQD3736, GFQD3737, GFQE4635, GFQE4636, GFQF0398, GFQF0399, GFQF0626, GFQF0627, GFQF3344, GFQF3345, GFQF3346, GFQF3348, GFQF3349, GFQF3350, GFQF4295, GFQF4298, GFQF4299, GFQF4300, GFQG2804, GFQG3632, GFQG3633, GFQG4404, GFQH1231, GFQH1232, GFQH1233, GFQH1234, GFQH1235, GFQH3834, GFQH3835, GFQH3836, GFQI0220, GFQI0221, GFQI0222, GFQI0223, GFQI0224, GFQI0225, GFQI0226, GFQI0227, GFQI0228, GFQI3991, GFQI3993 & GFQI3996
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide including USA, Australia, and Canada
  • 제품 설명
    G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc