Z-0585-04

Cruciform Slit Valve

Name: Z-0585-04 Cruciform Slit Valve
Creator: Phoenix Biomedical
Published: 2004-01-06
License: https://open.fda.gov/license/

Phoenix Biomedical Corp. / initiated 2004-01-06 / Terminated / root cause: labeling and UDI

FDA source

Phoenix Biomedical began a recall of Cruciform Slit Valve on 2004-01-06. The reason FDA records is "mislabeled - product actually Single Valve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0585-04
Status: Terminated
Initiated: 2004-01-06
Posted: 2004-07-20
Terminated: 2004-03-03
Recalling firm: Phoenix Biomedical Corp.
Product: Cruciform Slit Valve
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: mislabeled - product actually Single Valve
Root cause tag: labeling and UDI
FDA 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 in commerce: 5 units
Distribution: The product was shipped to two hospitals - one in CA and one in AZ.
Product codes and lots: UbaV/V020/07-2003

Product code JXG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)