SunMed Holdings, LLC: Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF114

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: 10889483075814 (Item # AF1000MBN-20, Case UDI: 30889483075818); UDI-DI: 10889483076606 (Item # AF1100MB, Case UDI: 30889483076600); UDI-DI: 10889483076613 (Item # AF1100MB-MMC, Case UDI: 30889483076617); UDI-DI: 10889483075838 (Item # AF1100MB-N, Case UDI: 30889483075832); UDI-DI: 10889483088074 (Item # AF1100MBP, Case UDI: 30889483088078); UDI-DI: 10889483086209 (Item # AF1100MB-PWG1, Case UDI: 30889483086203); UDI-DI: 10889483086216 (Item # AF1100MBS, Case UDI: 30889483086210); UDI-DI: 10889483094365 (Item # AF1100MC, Case UDI: 30889483094369); UDI-DI: 10889483159217 (Item # AF1100MC-P, Case UDI: 30889483159211); UDI-DI: 10889483071809 (Item # AF1140MB, Case UDI: 30889483071803); UDI-DI: 10889483230626 (Item # AF1140MBC-N Case UDI: 30889483230620); UDI-DI: 10889483090718 (Item # AF1140MB-D5, Case UDI: 30889483090712); UDI-DI: 10889483106372 (Item # AF1140MB-E, Case UDI: 30889483106376); UDI-DI: 10889483095096 (Item # AF1140MB-I, Case UDI: 30889483095090); UDI-DI: 10889483083918 (Item # AF1140MB-K, Case UDI: 30889483083912); UDI-DI: 10889483162224 (Item # AF1140MB-M5, Case UDI: 30889483162228); UDI-DI: 10889483094372 (Item # AF1140MB-N, Case UDI: 30889483094376); UDI-DI: 10889483098370 (Item # AF1140MB-P, Case UDI: 30889483098374); UDI-DI: 10889483101469 (Item # AF1140MBP-2, Case UDI: 30889483101463); UDI-DI: 10889483106396 (Item # AF1140MBP-K, Case UDI: 30889483106390); UDI-DI: 10889483076637 (Item # AF1140MBP-M5, Case UDI: 30889483076631); UDI-DI: 10889483078143 (I

UPC codes

10889483075814, 30889483075818, 10889483076606, 30889483076600, 10889483076613, 30889483076617, 10889483075838, 30889483075832, 10889483088074, 30889483088078, 10889483086209, 30889483086203, 10889483086216, 30889483086210, 10889483094365, 30889483094369, 10889483159217, 30889483159211, 10889483071809, 30889483071803, 10889483230626, 30889483230620, 10889483090718, 30889483090712, 10889483106372, 30889483106376, 10889483095096, 30889483095090, 10889483083918, 30889483083912, 10889483162224, 30889483162228, 10889483094372, 30889483094376, 10889483098370, 30889483098374, 10889483101469, 30889483101463, 10889483106396, 30889483106390

Source

Official record: FDA (Device enforcement) ↗

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