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.
FDA Recall Z-2435-2010 · Posted 2010-09-19
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Recalling FirmVentus Medical, Inc.
Recall StatusTerminated
Product CodeMNR
Date Initiated2009-12-03
Date Terminated2011-03-11
Product Quantity60
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 .
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Product was distributed in the US through a single distribution supplier.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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