SunMed Holdings, LLC: Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Che

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: 10889483109250, (Item # SC7101B, Case UDI: 30889483109254); UDI-DI: 10889483160671, (Item # SC7101B-M0. Case UDI: 30889483160675); UDI-DI: 10889483110041, (Item # SC8121B, Case UDI: 30889483110045); UDI-DI: 10889483098677, (Item # SC9101B , Case UDI: 30889483098671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

UPC codes

10889483109250, 30889483109254, 10889483160671, 30889483160675, 10889483110041, 30889483110045, 10889483098677, 30889483098671

Source

Official record: FDA (Device enforcement) ↗

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