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SunMed Holdings, LLC recalls Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A
Recalled November 29, 2023 · FDA recall Z-0368-2024 · 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
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
Manufacturer(s)
SunMed Holdings, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →