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SunMed Holdings, LLC recalls Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1
Recalled November 29, 2023 · FDA recall Z-0365-2024 · SunMed Holdings
Hazard
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. · FDA Class II
Units
N/A
Sold at
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.
Description
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Product
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.
Manufacturer(s)
SunMed Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →