The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of re
FDA device recall Z-2435-2010 · posted 2010-09-19 · Terminated
Recall details
- Recalling firm
- Ventus Medical, Inc.
- 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 .
- Action taken
- 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
- Status
- Terminated
- Product code
- MNR
- Quantity affected
- 60
- Distribution
- Product was distributed in the US through a single distribution supplier.
- Date initiated
- 2009-12-03
- Date posted
- 2010-09-19
- Date terminated
- 2011-03-11
- Location
- Belmont, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROVENT NASAL CANNULA (K080983) | Ventus Medical, Inc. | 2008-08-07 |