Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.
FDA Recall Z-2009-2009 · Posted 2009-09-16
Recalling FirmCarleton Life Support Systems Inc
Recall StatusTerminated
Product CodeCAW
Date Initiated2009-07-24
Date Terminated2012-03-22
Product Quantity23 units
Reason for Recall
The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.
Firm Action
Cobham Life Support Systems, Inc. issued letters to their two customers via e-mail. One customer letter was dated July 24, 2009 and the other was dated July 28, 2009. Both letters notified the customer of the reason for the recall and that the usage of the concentrator must be restricted to exclude actual use with a patient until corrected. The letter informs customers they are redesigning the backup supply control valve and will coordinate the retrofit in the future.
For further information, contact Cobham Life Support at 1-563-383-6421.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution -- CT and AL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.