FDA recall Z-0337-2023

Caire, Inc. · Class I · device

Product

CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

Reason for recall

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.

Distribution

US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany

Key facts

Status
Terminated
Initiation date
2022-10-10
Report date
2022-12-14
Termination date
2024-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ball Ground, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0337-2023