Recall Z-3288-2011 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
Respironics Novametrix, LLC.
FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
| Date | Sep 30, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Root cause | Manufacturing material removal |
| Action | Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information. |
| Quantity | 41 units |
| Distribution | Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia. |
| FDA record | Open on fda.gov |