Recall Z-2435-2010 ยท MNR Ventilatory Effort Recorder
Ventus Medical, Inc.
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.
| Date | Sep 19, 2010 (initiated Dec 3, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 60 |
| Distribution | Product was distributed in the US through a single distribution supplier. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080983 | PROVENT NASAL CANNULA Ventus Medical, Inc., Aug 7, 2008 |