FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Pulmonary Valve & Conduit
- Recall number
- Z-0165-05
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Pulmonary 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
- 17 units
- Distribution
- Nationwide, Austria, Canada, Germany
- Lot, serial or model codes
- Donor #40003, Serial #6528309, Model #PV00* Donor #40017, Serial #6528244, Model #PV00* Donor #41194, Serial #6575765, Model #PV00* Donor #41205, Serial #6575951, Model #PV00* Donor #41983, Serial #6601316, Model #PV00* Donor #45463, Serial #6708282, Model #PV00* Donor #45539, Serial #6697697, Model #PV00* Donor #45616, Serial #6735116, Model #PV00* Donor #46477, Serial #6741538, Model #PV00* Donor #46894, Serial #6768760, Model #PV00* Donor #49793, Serial #6888973, Model #PV00* Donor #50045, Serial #7110175, Model #PV00* Donor #50982, Serial #7004457, Model #PV00* Donor #50986, Serial #7048353, Model #PV00* Donor #51902, Serial #7037079, Model #PV00* Donor #59101, Serial #7387145, Model #PV00* Donor #61954, Serial #7682701, Model #PV00
- 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