CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
This recall has been terminated (originally issued December 2, 2022).
- Company
- Caire, Inc.
- Recall Initiated
- October 10, 2022
- Posted
- December 2, 2022
- Terminated
- August 19, 2024
- Recall Number
- Z-0339-2023
- Quantity
- 3 units
- Firm Location
- Ball Ground, GA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Lot / Code Info
UDI/DI M766133374030M766132561950, Serial Numbers: CBB3022320073, CBB3022320077, CBB3022320074
Root 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.