SunMed Holdings, LLC: Medical Device Recall in 2023 - (Recall #: Z-0365-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: October 11, 2023

Date Posted: November 29, 2023

Recall Number: Z-0365-2024

Event ID: 93237

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

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.

Voluntary or Mandated:

Voluntary: Firm initiated