Z-2435-2010

The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for...

Name: Z-2435-2010 The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for...
Creator: Ventus Medical, Inc.
Published: 2009-12-03
License: https://open.fda.gov/license/

Ventus Medical, Inc. / initiated 2009-12-03 / Terminated / root cause: labeling and UDI

FDA source

Ventus Medical, Inc. began a recall of The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the... on 2009-12-03. The reason FDA records is "The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No...". 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-2435-2010
Status: Terminated
Initiated: 2009-12-03
Posted: 2010-09-19
Terminated: 2011-03-11
Recalling firm: Ventus Medical, Inc.
Product: The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
Product code: MNR Ventilatory Effort Recorder
Reason for recall: The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient .
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Ventus Medical, Inc. of Belmont, CA has notified all customers who received distribution from the affected manufacturing lot (1880783) to immediately return the product in question for replacement. If there are any questions regarding this correction, please contact the firm at (650) 632-4165.
Quantity in commerce: 60
Distribution: Product was distributed in the US through a single distribution supplier.
Product codes and lots: Catalog Number: MRS0208 Lot Number: 1880783

Product code MNR

K080983Class IIProvent Nasal CannulaVentus Medical, Inc. / cleared 2008-08-07

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)