CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
FDA device recall Z-0338-2023 · posted 2022-12-02 · Terminated
Recall details
- Recalling firm
- Caire, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BYJ
- Quantity affected
- 5 devices
- Distribution
- US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
- Date initiated
- 2022-10-10
- Date posted
- 2022-12-02
- Date terminated
- 2024-08-19
- Location
- Ball Ground, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIBERATOR/STROLLER II SYSTEM (K800742) | Cryogenic Assoc. | 1980-05-23 |