Device Recall Recovery G2 의 리콜

Recall

37021

Class 2

Z-0394-2007

2006-12-20

2007-02-01

Terminated

United States

2008-10-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49777

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.

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.