CPS Valve Bypass Tool (VBT), Model 410192
FDA Recall Z-1165-06 · Posted 2006-06-24
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Recalling FirmSt Jude Medical CRMD
Recall StatusTerminated
Product CodeDQY
Date Initiated2006-06-01
Date Terminated2012-03-26
Product Quantity775
Reason for Recall
Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
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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