Events

Recall of Device Recall G2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37021
  • Event Risk Class
    Class 2
  • Event Number
    Z-0393-2007
  • Event Initiated Date
    2006-12-20
  • Event Date Posted
    2007-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49776
  • Notes / Alerts
    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.
  • Extra notes in the data
    embolism filter - Product Code DTK
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide including USA, Australia, and Canada
  • Product Description
    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
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA