FDA Medical Device Recalls (openFDA)
CryoLife, Inc.: Pulmonary Hemi-Artery SG Used in heart surgery
- Recall number
- Z-0809-2014
- Recalling firm
- CryoLife, Inc.
- Product
- Pulmonary Hemi-Artery SG Used in heart surgery
- Status
- Terminated
- Initiated
- 2013-11-22
- Posted
- 2014-01-23
- Terminated
- 2014-02-20
- Reason
- Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
- Root cause
- Other
- Action
- CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.
- Quantity
- One
- Distribution
- US distribution in CA.
- Lot, serial or model codes
- Serial No. 10119759, 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