SunMed Holdings, LLC: Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116

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:10888277628298, (Case UDI: 20888277698885, ITEM # CPRM1116FM); UDI-DI:10888277667785, (Case UDI: 20888277667782, ITEM # CPRM1116FMT); UDI-DI:10888277654815, (Case UDI: 20888277654812, ITEM # CPRM1116FPM); UDI-DI:10193489082685, (Case UDI: 20193489021544, ITEM # CPRM1116FPM4); UDI-DI:10888277628304, (Case UDI: 20888277628301, ITEM # CPRM1116M); UDI-DI:10888277698826, (Case UDI: 20888277698823, ITEM # CPRM1116MC); UDI-DI:10888277628311, (Case UDI: 20888277628318, ITEM # CPRM1116PM); UDI-DI:10888277674004, (Case UDI: 20888277674001, ITEM # CPRM1116PMT); UDI-DI:10888277629677, (Case UDI: 20888277629674, ITEM # CPRM1126FM); UDI-DI:10884389810293, (Case UDI: 20884389810290, ITEM # CPRM1126FPM); UDI-DI:10193489001945, (Case UDI: 20193489001942, ITEM # CPRM1126FPWM); UDI-DI:10888277628328, (Case UDI: 20888277628325, ITEM # CPRM1126M); UDI-DI:10888277655140, (Case UDI: 20888277655147, ITEM # CPRM2216FM); UDI-DI:10888277698857, (Case UDI: 20888277717678, ITEM # CPRM2216FM3); UDI-DI:10888277632332, (Case UDI: 20888277632339, ITEM # CPRM2216FPM); UDI-DI:10193489001150, (Case UDI: 20193489001157, ITEM # CPRM2216FPM3); UDI-DI:10193489181937, (Case UDI: 20193489181934, ITEM # CPRM2216FPMC); UDI-DI:10888277632349, (Case UDI: 20888277632346, ITEM # CPRM2216M); UDI-DI:10193489009750, (Case UDI: 20193489009757, ITEM # CPRM2216P3M3); UDI-DI:10888277669833, (Case UDI: 20888277669830, ITEM # CPRM2216PCM); UDI-DI:10888277629684, (Case UDI: 20888277629681, ITEM # CPRM2216PM); UDI-DI:101934890

UPC codes

10888277628298, 20888277698885, 10888277667785, 20888277667782, 10888277654815, 20888277654812, 10193489082685, 20193489021544, 10888277628304, 20888277628301, 10888277698826, 20888277698823, 10888277628311, 20888277628318, 10888277674004, 20888277674001, 10888277629677, 20888277629674, 10884389810293, 20884389810290, 10193489001945, 20193489001942, 10888277628328, 20888277628325, 10888277655140, 20888277655147, 10888277698857, 20888277717678, 10888277632332, 20888277632339, 10193489001150, 20193489001157, 10193489181937, 20193489181934, 10888277632349, 20888277632346, 10193489009750, 20193489009757, 10888277669833, 20888277669830

Source

Official record: FDA (Device enforcement) ↗

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