FDA Medical Device Recalls (openFDA)
Phoenix Biomedical: Cruciform Slit Valve
- Recall number
- Z-0585-04
- Recalling firm
- Phoenix Biomedical
- Product
- Cruciform Slit Valve
- Status
- Terminated
- Initiated
- 2004-01-06
- Posted
- 2004-07-20
- Terminated
- 2004-03-03
- Reason
- mislabeled - product actually Single Valve
- Root cause
- Other
- Action
- The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.
- Quantity
- 5 units
- Distribution
- The product was shipped to two hospitals - one in CA and one in AZ.
- Lot, serial or model codes
- UbaV/V020/07-2003
- 510(k) numbers
- ["K790126","K853363"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 2518608
- Firm city
- Norristown
- Firm state
- PA
- 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