Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.

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

Code information: ITEM # VN2100MB, UDI-DI: 10889483095379, (Case UDI: 30889483095373); ITEM # VN2100MBF, UDI-DI: 10889483092774, (Case UDI: 30889483092778); ITEM # VN2100MBP, UDI-DI: 10889483108260, (Case UDI: 30889483108264); ITEM # VN2100MB-PW, UDI-DI: 10889483108253, (Case UDI: 30889483108257); ITEM # VN2100MC, UDI-DI: 10889483108277, (Case UDI: 30889483108271); ITEM # VN2100MCP, UDI-DI: 10889483094525, (Case UDI: 30889483094529); ITEM # VN2100MX-M123, UDI-DI: 10889483098936, (Case UDI: 30889483098930); ITEM # VN2102MB, UDI-DI: 10889483105542, (Case UDI: 30889483105546); ITEM # VN2102MBF, UDI-DI: 10889483110966, (Case UDI: 30889483110960); ITEM # VN2102MC, UDI-DI: 10889483111994, (Case UDI: 30889483111998); ITEM # VN2102MC-B, UDI-DI: 10889483107393, (Case UDI: 30889483107397); ITEM # VN2102MCP, UDI-DI: 10889483088470, (Case UDI: 30889483088474); ITEM # VN2102MX, UDI-DI: 10889483095751, (Case UDI: 30889483095755); ITEM # VN2102MX-F, UDI-DI: 10889483105863, (Case UDI: 30889483105867); ITEM # VN2102OBP, UDI-DI: 10889483108895, (Case UDI: 30889483108899); ITEM # VN3100MB, UDI-DI: 10889483096994, (Case UDI: 30889483096998); ITEM # VN3100MB-2, UDI-DI: 10889483105900, (Case UDI: 30889483105904); ITEM # VN3100MB-B, UDI-DI: 10889483113585, (Case UDI: 30889483113589); ITEM # VN3100MB-D1, UDI-DI: 10889483105566, (Case UDI: 30889483105560); ITEM # VN3100MBF, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MB-I, UDI-DI: 10889483109380, (Case UDI: 30889483109384); ITEM # VN3100MB-M00- 0, UDI-DI: 10889483095980, (Case UDI: 30889483095984); ITEM # VN3100MB-M01, UDI-DI: 10889483110386, (Case UDI: 30889483110380); ITEM # VN3100MB-M1, UDI-DI: 10889483102763, (Case UDI: 30889483102767); ITEM # VN3100MBP, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MBP-000, UDI-DI: 10889483110393, (Case UDI: 30889483110397); ITEM # VN3100MBP-2, UDI-DI: 10889483104262, (Case UDI: 30889483104266); ITEM # VN3100MBP-3M, UDI-DI: 10889483100639, (Case UDI: 30889483100633); ITEM # VN3100MBP-D1, UDI-DI: 10889483110751, (Case UDI: 30889483110755); ITEM # VN3100MBP-F, UDI-DI: 10889483102770, (Case UDI: 30889483102774); ITEM # VN3100MB-PW2, UDI-DI: 10889483110744, (Case UDI: 30889483110748); ITEM # VN3100MBPW-D2, UDI-DI: 10889483111192, (Case UDI: 30889483111196); ITEM # VN3100MC, UDI-DI: 10889483100646, (Case UDI: 30889483100640); ITEM # VN3100MC-2, UDI-DI: 10889483111208, (Case UDI: 30889483111202); ITEM # VN3100MC-2U, UDI-DI: 10889483112113, (Case UDI: 30889483112117); ITEM # VN3100MC-B, UDI-DI: 10889483095768, (Case UDI: 30889483095762); ITEM # VN3100MC-D1, UDI-DI: 10889483112021, (Case UDI: 30889483112025); ITEM # VN3100MCP, UDI-DI: 10889483110768, (Case UDI: 30889483110762); ITEM # VN3100MCP-2, UDI-DI: 10889483113622, (Case UDI: 30889483113626); ITEM # VN3100MX-F, UDI-DI: 10889483112038, (Case UDI: 30889483112032); ITEM # VN3100MXK-2, UDI-DI: 10889483111215, (Case UDI: 30889483111219); ITEM # VN3100OB, UDI-DI: 10889483099964, (Case UDI: 30889483099968); ITEM # VN3100OBP, UDI-DI: 10889483105924, (Case UDI: 30889483105928); ITEM # VN3104MCFB- M01, UDI-DI: 10889483110775, (Case UDI: 30889483110779); ITEM # VN3106MC-D2V, UDI-DI: 10889483107539, (Case UDI: 30889483107533); ITEM # VN3106MC-M1- 2V, UDI-DI: 10889483095997, (Case UDI: 30889483095991); ITEM # VN3106MC-M1V, UDI-DI: 10889483097991, (Case UDI: 30889483097995); ITEM # VN3106MCPF- M1V, UDI-DI: 10889483099001, (Case UDI: 30889483099005); ITEM # VN4100MB, UDI-DI: 10889483111338, (Case UDI: 30889483111332); ITEM # VN4100MCFB-3, UDI-DI: 10889483111239, (Case UDI: 30889483111233); ITEM # VN4100MCP, UDI-DI: 10889483098042, (Case UDI: 30889483098046); ITEM # VN5000MB, UDI-DI: 10889483112052, (Case UDI: 30889483112056); ITEM # VN5000MBPF, UDI-DI: 10889483112229, (Case UDI: 30889483112223); ITEM # VN5000MBPF-I, UDI-DI: 10889483113646, (Case UDI: 30889483113640); ITEM # VN5000MC, UDI-DI: 10889483095393, (Case UDI: 30889483095397); ITEM # VN5000MC-N, UDI-DI: 10889483108352, (Case UDI: 30889483108356); ITEM # VN5000MX, UDI-DI: 10889483107782, (Case UDI: 30889483107786); ITEM # VN5000MX-N, UDI-DI: 10889483107553, (Case UDI: 30889483107557); ITEM # VN5000MXP, UDI-DI: 10889483089828, (Case UDI: 30889483089822); ITEM # VN5000MXP-K, UDI-DI: 10889483110409, (Case UDI: 30889483110403); ITEM # VN5002MB, UDI-DI: 10889483100660, (Case UDI: 30889483100664); ITEM # VN5100MB-F, UDI-DI: 10889483107560, (Case UDI: 30889483107564); ITEM # VN5100MCP, UDI-DI: 10889483098554, (Case UDI: 30889483098558); ITEM # VN5100MX-F, UDI-DI: 10889483095782, (Case UDI: 30889483095786); ITEM # VN5102MC, UDI-DI: 10889483109403, (Case UDI: 30889483109407); ITEM # VNW3100MB-2, UDI-DI: 10889483100677, (Case UDI: 30889483100671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern: 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.