Z-0300-04

MVP-10 Pediatric/ Neonatal Volume Ventilator

Name: Z-0300-04 MVP-10 Pediatric/ Neonatal Volume Ventilator
Creator: Bio-Med Devices, Inc.
Published: 2003-11-07
License: https://open.fda.gov/license/

Bio-Med Devices, Inc. / initiated 2003-11-07 / Terminated

FDA source

Bio-Med Devices, Inc. began a recall of MVP-10 Pediatric/ Neonatal Volume Ventilator on 2003-11-07. The reason FDA records is "Two way relief valve may fail to activate at the low negative pressure of -3cm H2O". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0300-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2004-01-06
Terminated: 2016-02-01
Recalling firm: Bio-Med Devices, Inc.
Product: MVP-10 Pediatric/ Neonatal Volume Ventilator
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
FDA root cause: Other
Action: Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.
Quantity in commerce: 3 units
Distribution: ID, PA, TX
Product codes and lots: S/N: 3023031, 3025031, 0957951

Product code MNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)