Pulmonary Valve & Conduit SG Used in heart surgery
FDA device recall Z-1219-2011 · posted 2011-02-11 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- Reason for recall
- A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
- Action taken
- 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
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- One
- Distribution
- Nationwide distribution: USA state of: MI
- Date initiated
- 2011-01-07
- Date posted
- 2011-02-11
- Date terminated
- 2011-11-01
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYOVALVE SG PULMONARY VALVE AND CONDUIT (K083106) | Cryolife, Inc. | 2009-02-06 |