Z-3288-2011

FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005

Name: Z-3288-2011 FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
Creator: Respironics Novametrix, LLC.
Published: 2011-07-29
License: https://open.fda.gov/license/

Respironics Novametrix, LLC. / initiated 2011-07-29 / Terminated / root cause: manufacturing process

FDA source

Respironics Novametrix, LLC. began a recall of FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 on 2011-07-29. The reason FDA records is "Pressure lines maybe occluded and display incorrect tidal volumes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3288-2011
Status: Terminated
Initiated: 2011-07-29
Posted: 2011-09-30
Terminated: 2012-05-23
Recalling firm: Respironics Novametrix, LLC.
Product: FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
Product code: BZK Spirometer, Monitoring (W/Wo Alarm)
Reason for recall: Pressure lines maybe occluded and display incorrect tidal volumes.
Root cause tag: manufacturing process
FDA 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 in commerce: 41 units
Distribution: Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
Product codes and lots: 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.

Product code BZK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)