FDA Medical Device Recalls (openFDA)
LifeNet: Pulmonary heart valve allograft, human tissue for transplantation.
- Recall number
- Z-0525-03
- Recalling firm
- LifeNet
- Product
- Pulmonary heart valve allograft, human tissue for transplantation.
- Status
- Terminated
- Initiated
- 2002-12-19
- Posted
- 2003-02-01
- Terminated
- 2003-01-27
- Reason
- Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
- Root cause
- Other
- Action
- Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned.
- Quantity
- 1 valve
- Distribution
- Product was shipped to one hospital in NY
- Lot, serial or model codes
- 01-0293HV-02
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIE
- Firm FEI
- 1000512996
- Firm city
- Virginia Beach
- Firm state
- VA
- 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