Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***
FDA Recall Z-0394-2007 · Posted 2007-02-01
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Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeDTK
Date Initiated2006-12-20
Date Terminated2008-10-23
Product Quantity124 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide including USA, Australia, and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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