Recall Z-1716-2008
Caire, Inc. · initiated October 23, 2007
Product
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
Codes / lots: Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1716-2008
- Initiated
- October 23, 2007
- Posted by FDA
- August 26, 2008
- Terminated
- December 17, 2009
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Quantity
- 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.
- Recalling firm
- Caire, Inc., Marietta, GA