SunMed Holdings, LLC: Ventlab and Curaplex Manual Resuscitators Recalled for CO2 Rebreathing Risk

What You Should Do

1. Identify if you have an affected resuscitator by checking the brand name and reference numbers (REF #) on the device packaging or the device itself. Affected brands include Ventlab AirFlow, BreathTech, Horizon, RescuMed, SafeSpot, STAT-Check, V-Care, Curaplex, and Medline.
2. Specifically check for products manufactured from September 21, 2018, to the present, with expiration dates as late as October 11, 2028. Key reference numbers include AF1140MB, BT2014, 9122HZ, BVM510-F, SS3200MB, SC7101B, VN4100MB, 2442-BVMPAD, and CPRM1116FPM among many others listed in the recall.
3. Examine the Unique Device Identifier (UDI-DI) codes on the product label, such as 10889483075814 for AirFlow or 10889483090787 for BreathTech, to confirm if your specific unit is part of the recall.
4. Stop using any affected resuscitator immediately and quarantine the devices to ensure they are not used in a medical emergency.
5. Contact your healthcare provider or SunMed Holdings, LLC directly for instructions on how to return the defective devices and to arrange for replacements or credits.
6. For further information or to report a problem, contact the FDA at 1-888-463-6332 or visit the official FDA medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products