SunMed Holdings, LLC: Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep V

Hazard

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

Details from the source

Reason for recall: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. 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 Lot/code info: UDI-DI: 00810071633126, Item # 2442-BVMCIN; UDI-DI: 00812277037050, Item # 2442-BVMPAD; UDI-DI: 00812277037074, Item # 2442-BVMPCH; UDI-DI: 00812277037081, Item # 2442-BVMPIN; UDI-DI: 00812277037067, Item # 2442-BVMPSA. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

UPC codes

00810071633126, 00812277037050, 00812277037074, 00812277037081, 00812277037067

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.