FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: Pulmonary Valve & Conduit SG Used in heart surgery
- Recall number
- Z-1219-2011
- Recalling firm
- CryoLife, Inc.
- Product
- Pulmonary Valve & Conduit SG Used in heart surgery
- Status
- Terminated
- Initiated
- 2011-01-07
- Posted
- 2011-02-11
- Terminated
- 2011-11-01
- Reason
- A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
- Root cause
- Other
- 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.
- Quantity
- One
- Distribution
- Nationwide distribution: USA state of: MI
- Lot, serial or model codes
- Serial Number 9748180
- 510(k) numbers
- ["K083106"]
- PMA numbers
- not on file
- Product code
- MIE
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28