FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
This recall has been terminated (originally issued September 30, 2011).
- Company
- Respironics Novametrix, Llc.
- Recall Initiated
- July 29, 2011
- Posted
- September 30, 2011
- Terminated
- May 23, 2012
- Recall Number
- Z-3288-2011
- Quantity
- 41 units
- Firm Location
- Wallingford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Pressure lines maybe occluded and display incorrect tidal volumes.
Distribution
Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
Lot / Code Info
Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834.
Root Cause
Manufacturing material removal
Action Taken
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.