Reported Nov 29, 2023 · Ongoing
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.…
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include
4 of 4 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
66 of 66 products
Products covered by this recall Model / number Barcodes Product as published VN2100MB1088948309537930889483095373UDI-DI: 10889483095379, (Case UDI: 30889483095373) VN2100MBF1088948309277430889483092778UDI-DI: 10889483092774, (Case UDI: 30889483092778) VN2100MBP1088948310826030889483108264UDI-DI: 10889483108260, (Case UDI: 30889483108264) VN2100MB-PW1088948310825330889483108257UDI-DI: 10889483108253, (Case UDI: 30889483108257) VN2100MC1088948310827730889483108271UDI-DI: 10889483108277, (Case UDI: 30889483108271) VN2100MCP1088948309452530889483094529UDI-DI: 10889483094525, (Case UDI: 30889483094529) VN2100MX-M1231088948309893630889483098930UDI-DI: 10889483098936, (Case UDI: 30889483098930) VN2102MB1088948310554230889483105546UDI-DI: 10889483105542, (Case UDI: 30889483105546) VN2102MBF1088948311096630889483110960UDI-DI: 10889483110966, (Case UDI: 30889483110960) VN2102MC1088948311199430889483111998UDI-DI: 10889483111994, (Case UDI: 30889483111998) VN2102MC-B1088948310739330889483107397UDI-DI: 10889483107393, (Case UDI: 30889483107397) VN2102MCP1088948308847030889483088474UDI-DI: 10889483088470, (Case UDI: 30889483088474) VN2102MX1088948309575130889483095755UDI-DI: 10889483095751, (Case UDI: 30889483095755) VN2102MX-F1088948310586330889483105867UDI-DI: 10889483105863, (Case UDI: 30889483105867) VN2102OBP1088948310889530889483108899UDI-DI: 10889483108895, (Case UDI: 30889483108899) VN3100MB1088948309699430889483096998UDI-DI: 10889483096994, (Case UDI: 30889483096998) VN3100MB-21088948310590030889483105904UDI-DI: 10889483105900, (Case UDI: 30889483105904) VN3100MB-B1088948311358530889483113589UDI-DI: 10889483113585, (Case UDI: 30889483113589) VN3100MB-D11088948310556630889483105560UDI-DI: 10889483105566, (Case UDI: 30889483105560) VN3100MBF1088948310062230889483100626UDI-DI: 10889483100622, (Case UDI: 30889483100626) - Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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