notyard
09-04-2008, 08:38 AM
FDA class II recall:
PRODUCT
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit, Recall # Z-1716-2008
CODE
Liberator Base units - CBB300634***X - CBB300738***X. Includes units produced from week 34-2006 through week 38-2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caire, Inc., Marietta, GA, by a Technical Service Bulletin on/about October 23, 2007.
Manufacturer: Caire, Inc., Ball Ground, GA. Firm initiated recall is ongoing.
REASON
Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
VOLUME OF PRODUCT IN COMMERCE
3,470 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit, Recall # Z-1716-2008
CODE
Liberator Base units - CBB300634***X - CBB300738***X. Includes units produced from week 34-2006 through week 38-2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caire, Inc., Marietta, GA, by a Technical Service Bulletin on/about October 23, 2007.
Manufacturer: Caire, Inc., Ball Ground, GA. Firm initiated recall is ongoing.
REASON
Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
VOLUME OF PRODUCT IN COMMERCE
3,470 units
DISTRIBUTION
Nationwide and Internationally