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Terminated

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

FDA Recall Z-3288-2011 · Posted 2011-09-30

Recalling FirmRespironics Novametrix, LLC.
Recall StatusTerminated
Product CodeBZK
Date Initiated2011-07-29
Date Terminated2012-05-23
Product Quantity41 units

Reason for Recall

Pressure lines maybe occluded and display incorrect tidal volumes.

Firm 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.

Root Cause

Manufacturing material removal

Distribution Pattern

Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092217MERCURY VCO2Respironics Novametrix, Inc. · 2009-08-21K091459PHILIPS NM3 MONITOR, MODEL 7900Respironics Novametrix, LLC · 2009-07-28K080652MERCURY VCO2 MODULE WITH CAPNOSTAT 5Respironics Novametrix, LLC · 2008-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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