Device recall: CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Class I FDA enforcement event 90999. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
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
Caire, Inc. started this device recall on 10 Oct 2022. The firm address in the FDA record is in Ball Ground, GA. FDA put the recall in Class I. FDA event 90999 has 4 product records. The first FDA enforcement report date is 14 Dec 2022. The record gives the status Terminated, with the termination date 19 Aug 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Recalling firm
Caire, Inc., Ball Ground, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0336-2023 | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | 10 devices | Class I | Terminated | 14 Dec 2022 |
| Z-0337-2023 | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit | 70 devices | Class I | Terminated | 14 Dec 2022 |
| Z-0338-2023 | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit | 5 devices | Class I | Terminated | 14 Dec 2022 |
| Z-0339-2023 | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit | 3 units | Class I | Terminated | 14 Dec 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class I
- 8%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Oct 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Device | Class II | 4 |
| 25 Mar 2022 | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 | Device | Class II | 1 |
| 21 Nov 2019 | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intende | Device | Class II | 1 |
| 16 Sep 2019 | SAROS Oxygen System Model 3000 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0336-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90999. https://recallregister.com/fda/i/90999/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
- What quantity of product is in FDA event 90999?
- The event has 4 product records. The first record gives this quantity:
10 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 8% of the 839 device events that started in 2022 are in Class I.