Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
FDA device recall Z-1716-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Caire, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BYJ
- Quantity affected
- 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, Germa
- Date initiated
- 2007-10-23
- Date posted
- 2008-08-26
- Date terminated
- 2009-12-17
- Location
- Marietta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |