FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Aortic Valve & Conduit
- Recall number
- Z-0166-05
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Aortic Valve & Conduit
- Status
- Terminated
- Initiated
- 2004-05-06
- Posted
- 2004-11-03
- Terminated
- 2010-06-29
- Reason
- CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about May 6, 2004.
- Quantity
- 20 units
- Distribution
- Nationwide, Austria, Canada, Germany
- Lot, serial or model codes
- Donor #25741, Serial #6048048, Model #PV00* Donor #34696, Serial #6356176, Model #PV00* Donor #40017, Serial #6528252, Model #AV00* Donor #41180, Serial #6575609, Model #AV00* Donor #41204, Serial #6575862, Model #AV00* Donor #41737, Serial #6593488, Model #AV00* Donor #45446, Serial #6714974, Model #AV00* Donor #45592, Serial #6735875, Model #AV00* Donor #46183, Serial #6736590, Model #AV00* Donor #46484, Serial #6774373, Model #AV00* Donor #46505, Serial #6770996, Model #AV00* Donor #47518, Serial #6761788, Model #AV00* Donor #50045, Serial #7110160, Model #AV00* Donor #50098, Serial #7106597, Model #AV00* Donor #50953, Serial #7000596, Model #AV00* Donor #50982, Serial #7090443, Model #AV00* Donor #53789, Serial #7013389, Model #AV00* Donor #54935, Serial #7235057, Model #AV00* Donor #59111, Serial #7343716, Model #AV00* Donor #59407, Serial #7322607, Model #AV00
- 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