Z-0365-06

6 cm Catheter Reservoir with 10 cm extension

Name: Z-0365-06 6 cm Catheter Reservoir with 10 cm extension
Creator: Vygon Neuro
Published: 2005-03-24
License: https://open.fda.gov/license/

Phoenix Biomedical Corp. / initiated 2005-03-24 / Terminated / root cause: labeling and UDI

FDA source

Vygon Neuro began a recall of 6 cm Catheter Reservoir with 10 cm extension on 2005-03-24. The reason FDA records is "stylet in package is shorter than that claimed on the label". 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-0365-06
Status: Terminated
Initiated: 2005-03-24
Posted: 2006-01-10
Terminated: 2006-01-10
Recalling firm: Phoenix Biomedical Corp.
Product: 6 cm Catheter Reservoir with 10 cm extension
Product code: HCA Catheter, Ventricular
Reason for recall: stylet in package is shorter than that claimed on the label
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
Quantity in commerce: 49 units
Distribution: The product was shipped to a hospital in CA and a distributor in Germany.
Product codes and lots: M1475/PR06X/12-2009 and N0112/PR06X/03-2010

Product code HCA

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)