Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT) 의 리콜

Recall

35616

Class 2

Z-1165-06

2006-06-01

2006-06-24

Terminated

United States

2012-03-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46475

Sterility-some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.