FDA Medical Device Recalls (openFDA)
Respironics Novametrix, LLC.: FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
- Recall number
- Z-3288-2011
- Recalling firm
- Respironics Novametrix, LLC.
- Product
- FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
- Status
- Terminated
- Initiated
- 2011-07-29
- Posted
- 2011-09-30
- Terminated
- 2012-05-23
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K080652","K091459","K092217"]
- PMA numbers
- not on file
- Product code
- BZK
- Firm FEI
- 1219324
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28