FDA Device recall Z-0367-2024
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscita…
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscita… by Sunmed Holdings, citing A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0367-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-11 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sunmed Holdings |
| Distribution | US |
Product
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.
Reason
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Identifiers
| code_info | ITEM # VN2100MB, UDI-DI: 10889483095379, (Case UDI: 30889483095373); ITEM # VN2100MBF, UDI-DI: 10889483092774, (Cas…ITEM # VN2100MB, UDI-DI: 10889483095379, (Case UDI: 30889483095373); ITEM # VN2100MBF, UDI-DI: 10889483092774, (Case UDI: 30889483092778); ITEM # VN2100MBP, UDI-DI: 10889483108260, (Case UDI: 30889483108264); ITEM # VN2100MB-PW, UDI-DI: 10889483108253, (Case UDI: 30889483108257); ITEM # VN2100MC, UDI-DI: 10889483108277, (Case UDI: 30889483108271); ITEM # VN2100MCP, UDI-DI: 10889483094525, (Case UDI: 30889483094529); ITEM # VN2100MX-M123, UDI-DI: 10889483098936, (Case UDI: 30889483098930); ITEM # VN2102MB, UDI-DI: 10889483105542, (Case UDI: 30889483105546); ITEM # VN2102MBF, UDI-DI: 10889483110966, (Case UDI: 30889483110960); ITEM # VN2102MC, UDI-DI: 10889483111994, (Case UDI: 30889483111998); ITEM # VN2102MC-B, UDI-DI: 10889483107393, (Case UDI: 30889483107397); ITEM # VN2102MCP, UDI-DI: 10889483088470, (Case UDI: 30889483088474); ITEM # VN2102MX, UDI-DI: 10889483095751, (Case UDI: 30889483095755); ITEM # VN2102MX-F, UDI-DI: 10889483105863, (Case |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0367-2024%22
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