SunMed Holdings, LLC: Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB

Hazard

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

Details from the source

Reason for recall: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. Distribution: 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. Quantity: N/A Lot/code info: 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); UD

UPC codes

10889483104107, 30889483104105, 10889483102954, 30889483102958, 10889483092590, 30889483092594, 10889483104330, 30889483104334, 10889483172322, 30889483172326, 10889483104354, 30889483104358, 10889483104545, 30889483104549, 10889483105771, 30889483105775, 10889483086919, 30889483086913, 10889483104903, 30889483104907, 10889483107324, 30889483107328, 10889483103777, 30889483103771, 10889483103111, 30889483103115, 10889483086902, 30889483086906, 10889483103784, 30889483103788, 10889483103128, 30889483103122, 10889483107904, 30889483107908, 10889483086926, 30889483086920, 10889483231142, 30889483231146, 10889483107331, 30889483107335

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.