FDAClass IDecember 14, 2022

CAIRE Liberator 45 recall

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Why was CAIRE Liberator 45 recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845

Product
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Recalling firm
Caire, Inc.
Quantity
10 devices
Distribution
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Recall date
December 14, 2022
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls