Recall Z-0365-2024— SunMed Holdings, LLC

Name: FDA recall Z-0365-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-11

Class II · Ongoing

Class II FDA medical device recall by SunMed Holdings, LLC, initiated 2023-10-11. It names one FDA 510(k) clearance: K012842. 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.. Reason: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing..

Recalling firm: SunMed Holdings, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-10-11
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K012842 — V*CARE MANUAL RESUSCITATORVentlab Corp.·cleared 2001-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.