The Recall Desk
SevereFDA (Devices)·Z-0336-2023·Announced 2022-12-14

Caire Liberator 45 Liquid Oxygen System Recalled for Weld Defects

Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I medical device recall, which requires a minimum severity score of 4. No illnesses, injuries, or deaths have been reported related to these devices.

Plain-English summary

Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units, Model 13261699. These are medical oxygen delivery devices. The recalled units are identified by specific serial numbers provided by Caire, Inc.

An audit discovered inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of some units. This manufacturing defect was identified through quality control inspection.

The recalled devices have been distributed nationwide in the United States (California, North Carolina, Ohio, and Arizona) and internationally (Canada, Chile, Colombia, and Germany).

The recalled product

Product
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Delivery Systems
Hazard
  • weld-defect
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category