medical Class II Updated 2023-11-29

SunMed Holdings, LLC recalls Ventlab, LLC V-Care manual resuscitators with integrated man

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
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