Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1716-2008

Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable...

Caire, Inc. / initiated 2007-10-23 / Terminated / root cause: design

Caire, Inc. began a recall of Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit on . The reason FDA records is "Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1716-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Caire, Inc.
Product
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
Product code
BYJ Unit, Liquid-Oxygen, Portable
Reason for recall
Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
Root cause tag
design
FDA root cause
Device Design
Action
A Technical Service Bulletin was sent to consignees on/about October 23, 2007 to notify customers of the potential issue. Technical support and information for ordering replacement Generation 4 liquid gauges were offered. For technical concerns or if you have not received the notification from the firm, contact U.S. Technical Service at 1-800-482-2473 or European Technical Service at +44 (0) 797 1260077.
Quantity in commerce
3470
Distribution
U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.
Product codes and lots
Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007.