The Recall Desk
Agency classClass IOur severity: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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units
10

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.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Caire, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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