Z-1033-2012

Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units...

Name: Z-1033-2012 Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units...
Creator: Ventus Medical, Inc.
Published: 2012-02-03
License: https://open.fda.gov/license/

Ventus Medical, Inc. / initiated 2012-02-03 / Terminated / root cause: labeling and UDI

FDA source

Ventus Medical, Inc. began a recall of Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical... on 2012-02-03. The reason FDA records is "A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match". 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-1033-2012
Status: Terminated
Initiated: 2012-02-03
Posted: 2012-02-15
Terminated: 2012-02-15
Recalling firm: Ventus Medical, Inc.
Product: Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.
Product code: OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Reason for recall: A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.
Quantity in commerce: 288 units
Distribution: Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
Product codes and lots: Catalog number MRS0227; Lot number: 14261182.

Product code OHP

K090398Class IIProvent Professional Sleep Apnea TherapyVentus Medical, Inc. / cleared 2009-04-03

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)