FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: Pulmonary Hemi-Artery SG Used in heart surgery
- Recall number
- Z-1561-2011
- Recalling firm
- CryoLife, Inc.
- Product
- Pulmonary Hemi-Artery SG Used in heart surgery
- Status
- Terminated
- Initiated
- 2011-02-17
- Posted
- 2011-03-04
- Terminated
- 2012-04-24
- Reason
- Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- Root cause
- Other
- Action
- CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.
- Quantity
- One
- Distribution
- Nationwide Distribution including AZ & NV
- Lot, serial or model codes
- Serial No. 9528019 - Model SGPH00
- 510(k) numbers
- ["K101866"]
- PMA numbers
- not on file
- Product code
- DXZ
- 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