Recall Z-0795-2025— JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Class I · Ongoing
Class I FDA medical device recall by JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD, initiated 2024-12-09. It names one FDA 510(k) clearance: K230969. Product: JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L. Reason: Oxygen concentrator may melt or catch on fire during use..
- Recalling firm
- JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-09
- Firm location
- Danyang, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Reason for recall
Oxygen concentrator may melt or catch on fire during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.