Recall Z-0337-2023 ยท BYJ Unit, Liquid-Oxygen, Portable
Caire, Inc.
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
| Date | Dec 2, 2022 (initiated Oct 10, 2022) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800742 | LIBERATOR/STROLLER II SYSTEM Cryogenic Assoc., May 23, 1980 |