FDA Medical Device Recalls (openFDA)
Caire, Inc.: CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
- Recall number
- Z-0337-2023
- Recalling firm
- Caire, Inc.
- Product
- CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
- Status
- Terminated
- Initiated
- 2022-10-10
- Posted
- 2022-12-02
- Terminated
- 2024-08-19
- Reason
- 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
- 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 customerservice.usa@caireinc.com to arrange for the return and replacement of the above serial numbers.
- Quantity
- 70 devices
- Distribution
- US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
- Lot, serial or model codes
- UDI/DI M766132622530, Serial Numbers: CBB3022311044, CBB3022311042, CBB3022311043, CBB3022311040, CBB3022311242, CBB3022311098, CBB3022311093, CBB3022311094, CBB3022311077, CBB3022311053, CBB3022311049, CBB3022311065, CBB3022311051, CBB3022311075, CBB3022311078, CBB3022311097, CBB3022311096, CBB3022311079, CBB3022311045, CBB3022311046, CBB3022311236, CBB3022311230, CBB3022311217, CBB3022311231, CBB3022311164, CBB3022311225, CBB3022311226, CBB3022311133, CBB3022311192, CBB3022311163, CBB3022311216, CBB3022311228, CBB3022311227, CBB3022311162, CBB3022311198, CBB3022311211, CBB3022311202, CBB3022311155, CBB3022311135, CBB3022311171, CBB3022311121, CBB3022311106, CBB3022311109, CBB3022311108, CBB3022311084, CBB3022311083, CBB3022311092, CBB3022311081, CBB3022311082, CBB3022311141, CBB3022311131, CBB3022311136, CBB3022311183, CBB3022311178, CBB3022311130, CBB3022311179, CBB3022311139, CBB3022311177, CBB3022311105, CBB3022311146, CBB3022311172, CBB3022311140, CBB3022311125, CBB3022311169, CBB3022311068, CBB3022311176, CBB3022311170, CBB3022311180, CBB3022311057, CBB3022311129
- 510(k) numbers
- ["K800742"]
- PMA numbers
- not on file
- Product code
- BYJ
- Firm FEI
- 3004972304
- Firm city
- Ball Ground
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28