Z-0338-2023Class I

CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

Name: Z-0338-2023 CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Creator: Caire, Inc.
Published: 2022-10-10
License: https://open.fda.gov/license/

Caire, Inc. / initiated 2022-10-10 / Terminated / root cause: manufacturing process

FDA source

Caire, Inc. began a recall of CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit on 2022-10-10. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0338-2023
Classification: Class I
Status: Terminated
Initiated: 2022-10-10
Posted: 2022-12-02
Terminated: 2024-08-19
Recalling firm: Caire, Inc.
Product: CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Product code: BYJ Unit, Liquid-Oxygen, Portable
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm issued an URGENT: MEDICAL DEVICE RECALL notice its consignees be email and telephone. The notice explained the issue and requested the removal of the affected products from the field and return to CAIRE. CAIRE will immediately replace the above serial numbers with new Liberator devices. Please contact CAIRE Customer Service via phone at 1-800-482-2473 or 770-721-7700 or via email at [email protected] to arrange for the return and replacement of the above serial numbers.
Quantity in commerce: 5 devices
Distribution: US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Product codes and lots: UDI/DI M766133374030, Serial Numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, CBB3022300479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0338-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0336-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0337-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0338-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02
Z-0339-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02

Product code BYJ

K800742Class IILiberator/stroller II SystemCryogenic Assoc. / cleared 1980-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)