Summary
The FDA issued a Class I for CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit by Caire, Inc.. 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..
Details
Source
Device Recall
External ID
Z-0338-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product Description
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Lot/Code Info: UDI/DI M766133374030, Serial Numbers: CBB3022300368, CBB3022300390, CBB3022300470, CBB3022300472, CBB3022300479
Quantity Affected: 5 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.
Distribution
US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-10
Company
Ball Ground, GA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Caire, Inc. has 10 FDA actions in our database, including 9 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Caire, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Caire, Inc. have FDA actions?
Caire, Inc. has 10 FDA actions in our database, including 9 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0338-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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