FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Allograft, Heart valve
- Recall number
- Z-0672-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Allograft, Heart valve
- Status
- Terminated
- Initiated
- 2003-02-04
- Posted
- 2003-03-21
- Terminated
- 2003-07-16
- Reason
- Microorganisms were detected in distributed allografts.
- Root cause
- Other
- Action
- CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.
- Quantity
- 2 units
- Distribution
- The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
- Lot, serial or model codes
- Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
- 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