The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0338-2023·Announced 2022-12-14

FDA Class I Recall: CAIRE Liberator 30 Liquid Oxygen System Units

Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.

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: This is an FDA Class I medical device recall, which mandates a minimum severity score of 4. The weld defect on a critical component of a life-sustaining oxygen delivery device presents a reasonable probability of serious harm, including device failure and oxygen supply loss to dependent patients.

Plain-English summary

The CAIRE Liberator 30, Model 13337403 is a liquid oxygen system unit designed to deliver supplemental oxygen to patients. Caire, Inc. is recalling five units identified by the following serial numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, and CBB3022300479.

An FDA audit discovered inconsistencies in weld penetration on the longitudinal weld seam of the inner bottle on some units. These weld defects compromise the structural integrity of the oxygen containment system and could lead to oxygen leakage or device failure, potentially depriving patients of necessary oxygen supply.

The recalled devices were distributed throughout the United States and internationally to Canada, Chile, Colombia, and Germany. If you have a device with one of the affected serial numbers, do not use it. Contact Caire, Inc. and your healthcare provider immediately to arrange an alternative oxygen delivery system.

The recalled product

Product
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Manufacturer
Caire, Inc.
Category
Medical Device — Oxygen Delivery
Hazard
Affected units
5

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 (6)

  • UDI/DI M766133374030
  • Serial Numbers: CBB3022300368
  • CBB3022300390
  • CBB3022300470
  • CBB3022300472
  • CBB3022300479

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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