FDA Medical Device Recalls (openFDA)
DCI Donor Services Tissue Services Division: One heart and pericardium from donor 12144.
- Recall number
- Z-0677-03
- Recalling firm
- DCI Donor Services Tissue Services Division
- Product
- One heart and pericardium from donor 12144.
- Status
- Terminated
- Initiated
- 2002-08-20
- Posted
- 2003-03-26
- Terminated
- 2003-04-08
- Reason
- Human tissue was procured from donor using non-sterile instruments.
- Root cause
- Other
- Action
- Consignee was notified by memorandum on 8/20/2002.
- Quantity
- One heart and pericardium.
- Distribution
- GA
- Lot, serial or model codes
- Donor # 12144.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIE
- Firm FEI
- 1000307504
- Firm city
- Nashville
- Firm state
- TN
- 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