Z-0393-2007

G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary...

Name: Z-0393-2007 G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary...
Creator: Bard Peripheral Vascular Inc
Published: 2006-12-20
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2006-12-20 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J on 2006-12-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0393-2007
Status: Terminated
Initiated: 2006-12-20
Posted: 2007-02-01
Terminated: 2008-10-23
Recalling firm: Bard Peripheral Vascular Inc
Product: G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: 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.
FDA root cause: Other
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.
Quantity in commerce: 5761 units
Distribution: Worldwide including USA, Australia, and Canada
Product codes and lots: 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 code DTK

K052578Class IIBard G2 Filter System - Jugular/subclavian Delivery Kit, Model RF-320JBard Peripheral Vascular, Inc. / cleared 2005-11-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)