FDA-Device2022-12-14Class I
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Caire, Inc.
Hazard
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.
Sold states
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Affected count
10 devices
Manufactured in
2200 Airport Industrial Dr Ste 500, N/A, Ball Ground, GA, United States
Products
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0336-2023Don't want to check this manually?
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