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Terminated

Portable Oxygen Generator

FDA Recall Z-1368-05 · Posted 2005-08-12

Recalling FirmInogen, Inc
Recall StatusTerminated
Product CodeCAW
Date Initiated2005-08-01
Date Terminated2007-02-13
Product Quantity900

Reason for Recall

Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.

Firm Action

Recall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032818INOGEN ONE OXYGEN CONCENTRATORInogen, Inc. · 2004-05-13

Official Source

View FDA Recall →

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

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