Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. 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.

Reason: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information: UDI-DI: 10889483104107, (Case UDI: 30889483104105, Item # PRO-1927); UDI-DI: 10889483102954, (Case UDI: 30889483102958, Item # SS3200MB); UDI-DI: 10889483092590, (Case UDI: 30889483092594, Item # SS3200MB-2); UDI-DI: 10889483104330, (Case UDI: 30889483104334, Item #SS3200MB-D1); UDI-DI: 10889483172322, (Case UDI: 30889483172326, Item # SS3200MBF); UDI-DI: 10889483104354, (Case UDI: 30889483104358, Item # SS3200MBF-2); UDI-DI: 10889483104545, (Case UDI: 30889483104549, Item # SS3200MB-I); UDI-DI: 10889483105771, (Case UDI: 30889483105775, Item # SS3200MB-MMC); UDI-DI: 10889483086919, (Case UDI: 30889483086913, Item # SS3200MBP); UDI-DI: 10889483104903, (Case UDI: 30889483104907, Item # SS3200MBP-2); UDI-DI: 10889483107324, (Case UDI: 30889483107328, Item # SS3200MBP-2I); UDI-DI: 10889483103777, (Case UDI: 30889483103771, Item # SS3200MBP-M00); UDI-DI: 10889483103111, (Case UDI: 30889483103115, Item # SS3200MB-PW); UDI-DI: 10889483086902, (Case UDI: 30889483086906, Item # SS3200MB- PWS10); UDI-DI: 10889483103784, (Case UDI: 30889483103788, Item # SS3200MC); UDI-DI: 10889483103128, (Case UDI: 30889483103122, Item # SS3200MC-P2); UDI-DI: 10889483107904, (Case UDI: 30889483107908, Item # SS3200OB); UDI-DI: 10889483086926, (Case UDI: 30889483086920, Item # SS3200OBP); UDI-DI: 10889483231142, (Case UDI: 30889483231146, Item # SS3200OBPC-T); UDI-DI: 10889483107331, (Case UDI: 30889483107335, Item # SS3204MB); UDI-DI: 10889483158913, (Case UDI: 30889483158917, Item # SS3204MB-D12); UDI-DI: 10889483104354, (Case UDI: 30889483104358, Item # SS3204MBF-2); UDI-DI: 10889483160497, (Case UDI: 30889483160491, Item # SS3204MC-P2); UDI-DI: 10889483111734, (Case UDI: 30889483111738, Item # SS3206MCP-S1. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.