CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
FDA Recall Z-0337-2023 · Posted 2022-12-02
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Recalling FirmCaire, Inc.
Recall StatusTerminated
Product CodeBYJ
Date Initiated2022-10-10
Date Terminated2024-08-19
Product Quantity70 devices
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.
Firm 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 [email protected] to arrange for the return and replacement of the above serial numbers.
Root Cause
Process control
Distribution Pattern
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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