Pulmonary Valve & Conduit SG Used in heart surgery
FDA Recall Z-1219-2011 · Posted 2011-02-11
Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMIE
Date Initiated2011-01-07
Date Terminated2011-11-01
Product QuantityOne
Reason for Recall
A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
Firm Action
The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received.
If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.
Root Cause
Other
Distribution Pattern
Nationwide distribution: USA state of: MI
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.