BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-0365-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0365-2024
    Event ID
    93237
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SunMed Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 29, 2023
    Initiation Date
    October 11, 2023
    Classification Date
    November 21, 2023
    Address
    2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, 49544-9112, United States

    Description

    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 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); 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

    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