Recall Z-1716-2008 ยท BYJ Unit, Liquid-Oxygen, Portable
Caire, Inc.
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
| Date | Aug 26, 2008 (initiated Oct 23, 2007) |
| Status | Terminated |
| 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. |
| 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 | 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, Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050153 | SPIRIT, MODEL HAS Caire, Inc., Apr 15, 2005 |