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U.S. Department of Health and Human Services

Class 1 Device Recall Claire Liberator Oxygen Unit

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 Class 1 Device Recall Claire Liberator Oxygen Unitsee related information
Date Initiated by FirmOctober 10, 2022
Date PostedDecember 02, 2022
Recall Status1 Terminated 3 on August 19, 2024
Recall NumberZ-0336-2023
Recall Event ID 90999
510(K)NumberK800742 
Product Classification Unit, liquid-oxygen, portable - Product Code BYJ
ProductCAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
Code Information UDI/DI M766132616990, Serial Numbers: CBB3022310887, CBB3022310888, CBB3022310852, CBB3022310823, CBB3022310792, CBB3022310843, CBB3022310844, CBB3022310827, CBB3022310842, CBB3022310845
Recalling Firm/
Manufacturer		 Caire, Inc.
2200 Airport Industrial Dr Ste 500
Ball Ground GA 30107-4686
For Additional Information ContactSheril Ray
770-721-7719
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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 in Commerce10 devices
DistributionUS Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BYJ
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