FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Pulmonary Valve and Conduit
- Recall number
- Z-0548-04
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Pulmonary Valve and Conduit
- Status
- Terminated
- Initiated
- 2003-12-10
- Posted
- 2004-02-25
- Terminated
- 2004-07-23
- Reason
- As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
- Root cause
- Other
- Action
- The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.
- Quantity
- 1 unit
- Distribution
- The allograft was shipped to one physician in TX.
- Lot, serial or model codes
- Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
- 510(k) numbers
- not on file
- 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