JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Summary
The FDA issued a Class I for JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L by JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD. Reason: Oxygen concentrator may melt or catch on fire during use..
Details
Source
Device Recall
External ID
Z-0795-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Lot/Code Info: UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.
Quantity Affected: 6,520
Reason for Recall
Oxygen concentrator may melt or catch on fire during use.
Distribution
US: OH
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-09
Company
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 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD has 8 FDA actions in our database, including 1 recall and 7 clearances.
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 (JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD have FDA actions?
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD has 8 FDA actions in our database, including 1 recall and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0795-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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