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U.S. Department of Health and Human Services

Class 2 Device Recall Recovery G2

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 Class 2 Device Recall Recovery G2see related information
Date Initiated by FirmDecember 20, 2006
Date PostedFebruary 01, 2007
Recall Status1 Terminated 3 on October 23, 2008
Recall NumberZ-0394-2007
Recall Event ID 37021
510(K)NumberK052578 
Product Classification embolism filter - Product Code DTK
ProductRecovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***
Code Information Lot numbers: GFPK3279, GFPK3280, GFPK3281 & GFPK3282
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information ContactShari L. Allen, RAC
480-303-2720
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		Other
ActionRecall 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 Commerce124 units
DistributionWorldwide including USA, Australia, and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTK
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