Reported Nov 29, 2023 · Ongoing
Ventlab, LLC SafeSpot 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 SafeSpot manual resuscitators with integrated manometer, multiple
- accessory configurations to include1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflation Bag Reservoir, Manometer, PEEP Valve, and 40cm Pop-Off REF # PRO-1927
- Lot codes and dates
24 of 24 products
Products covered by this recall Model / number Barcodes Product as published PRO-1927108894831041073088948310410510889483104107, (Case UDI: 30889483104105, ) SS3200MB1088948310295430889483102958UDI-DI: 10889483102954, (Case UDI: 30889483102958, ) SS3200MB-21088948309259030889483092594UDI-DI: 10889483092590, (Case UDI: 30889483092594, ) SS3200MB-D11088948310433030889483104334UDI-DI: 10889483104330, (Case UDI: 30889483104334, ) SS3200MBF1088948317232230889483172326UDI-DI: 10889483172322, (Case UDI: 30889483172326, ) SS3200MBF-21088948310435430889483104358UDI-DI: 10889483104354, (Case UDI: 30889483104358, ) SS3200MB-I1088948310454530889483104549UDI-DI: 10889483104545, (Case UDI: 30889483104549, ) SS3200MB-MMC1088948310577130889483105775UDI-DI: 10889483105771, (Case UDI: 30889483105775, ) SS3200MBP1088948308691930889483086913UDI-DI: 10889483086919, (Case UDI: 30889483086913, ) SS3200MBP-21088948310490330889483104907UDI-DI: 10889483104903, (Case UDI: 30889483104907, ) SS3200MBP-2I1088948310732430889483107328UDI-DI: 10889483107324, (Case UDI: 30889483107328, ) SS3200MBP-M001088948310377730889483103771UDI-DI: 10889483103777, (Case UDI: 30889483103771, ) SS3200MB-PW1088948310311130889483103115UDI-DI: 10889483103111, (Case UDI: 30889483103115, ) SS3200MB-1088948308690230889483086906UDI-DI: 10889483086902, (Case UDI: 30889483086906, PWS10) SS3200MC1088948310378430889483103788UDI-DI: 10889483103784, (Case UDI: 30889483103788, ) SS3200MC-P21088948310312830889483103122UDI-DI: 10889483103128, (Case UDI: 30889483103122, ) SS3200OB1088948310790430889483107908UDI-DI: 10889483107904, (Case UDI: 30889483107908, ) SS3200OBP1088948308692630889483086920UDI-DI: 10889483086926, (Case UDI: 30889483086920, ) SS3200OBPC-T1088948323114230889483231146UDI-DI: 10889483231142, (Case UDI: 30889483231146, ) SS3204MB1088948310733130889483107335UDI-DI: 10889483107331, (Case UDI: 30889483107335, ) - 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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