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JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

FDA Recall #Z-0795-2025 — Class I — December 9, 2024

Recall #Z-0795-2025 Date: December 9, 2024 Classification: Class I Status: Ongoing

Product Description

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

Reason for Recall

Oxygen concentrator may melt or catch on fire during use.

Recalling Firm

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD — Danyang

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

6,520

Distribution

US: OH

Code Information

UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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