Recall Z-0338-2023
Caire, Inc. · initiated October 10, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Codes / lots: UDI/DI M766133374030, Serial Numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, CBB3022300479
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0338-2023
- Initiated
- October 10, 2022
- Posted by FDA
- December 2, 2022
- Terminated
- August 19, 2024
- Product code
- BYJ – Unit, Liquid-Oxygen, Portable
- Quantity
- 5 devices
- Distribution
- US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
- Recalling firm
- Caire, Inc., Ball Ground, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0336-2023 Class I | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-0337-2023 Class I | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |
| Z-0339-2023 Class I | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | 10/10/2022Terminated |