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U.S. Department of Health and Human Services

Class 2 Device Recall G2

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  Class 2 Device Recall G2 see related information
Date Initiated by Firm December 20, 2006
Date Posted February 01, 2007
Recall Status1 Terminated 3 on October 23, 2008
Recall Number Z-0393-2007
Recall Event ID 37021
510(K)Number K052578  
Product Classification embolism filter - Product Code DTK
Product G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J
Code Information 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
Recalling Firm/
Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact Shari L. Allen, RAC
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTK and Original Applicant = BARD PERIPHERAL VASCULAR, INC.