Unit, Liquid-oxygen, Portable
Anesthesiology · 21 CFR 868.5655
Recent MDR events
607 adverse event reports on file
- LIBERATORApr 8, 2026InjuryCaire Inc3004972304-2026-00003
- STROLLERMar 4, 2026InjuryCaire Inc3004972304-2026-00002
- LIBERATORJul 16, 2025DeathCaire Inc.3004972304-2025-00004
- LIBERATORDec 11, 2024DeathCaire Inc.3004972304-2024-00016
- LIBERATORDec 11, 2024InjuryCaire Inc.3004972304-2024-00015
- STROLLERNov 11, 2024MalfunctionCaire Inc.3004972304-2024-00013
- LIBERATORSep 3, 2024DeathCaire Inc.3004972304-2024-00010
- LIBERATORSep 3, 2024InjuryCaire Inc.3004972304-2024-00011
- STROLLERJul 16, 2024InjuryCaire Inc.3004972304-2024-00008
- STROLLERJul 12, 2024InjuryCaire Inc.3004972304-2024-00007
Event type breakdown
Recalls
6 recall events for this product code
- Caire, Inc.TerminatedDec 2, 2022
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Z-0336-2023 · View FDA record ↗ - Caire, Inc.TerminatedDec 2, 2022
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Z-0337-2023 · View FDA record ↗ - Caire, Inc.TerminatedDec 2, 2022
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Z-0338-2023 · View FDA record ↗ - Caire, Inc.TerminatedDec 2, 2022
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Z-0339-2023 · View FDA record ↗ - Caire, Inc.TerminatedAug 26, 2008
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
Z-1716-2008 · View FDA record ↗ - Precision Medical, Inc.TerminatedNov 4, 2006
Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067
Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.
Z-0153-2007 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
510(k) clearances
55 clearances for this product code
- Essex Industries, Inc. D/B/A Essex Cryogenics of MJul 19, 2013
K130068 · DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
- Essex Industries, Inc.Jun 29, 2012
K113767 · MOUNTED MEDICAL OXYGEN SYSTEM
- Precision Medical, Inc.Apr 21, 2011
K103324 · PRECISION LIQUID OXYGEN SYSTEM
- Essex Industries, Inc.Aug 20, 2010
K101272 · MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
- Respironics, Inc.Sep 19, 2008
K081779 · GOLOX-93
- Caire, Inc.Jun 16, 2008
K080023 · MODIFICATION TO: SPIRIT
- Respironics, Inc.Mar 20, 2008
K072723 · RESPIRONICS GOLOX
- Copd Partners, Inc.Oct 18, 2007
K072011 · COPD LIQUID OXYGEN PORTABLE, MODEL 300P