medical Class II Updated 2023-11-29

SunMed Holdings, LLC recalls Ventlab, LLC RescuMed manual resuscitators with integrated m

Recalled Product

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.

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: UDI-DI: 10889483164266, (ITEM # BVM510-F, Case UDI: 30889483184680); UDI-D: 10889483164754, (ITEM # BVMB710, Case UDI: 30889483164758); UDI-DI: 10889483164785, (ITEM # BVMB812, Case UDI: 30889483164789); UDI-DI: 10889483164761, (ITEM # BVMB812-F, Case UDI: 30889483164765); UDI-DI: 10889483169605, (ITEM # BVMB510-10, Case UDI: 30889483169609); UDI-DI: 10889483164686, (ITEM # BVMB510-F, Case UDI: 0889483164680); UDI-DI: 10889483164693, (ITEM # BVMB510S-F, Case UDI: 3088948316469); UDI-DI: 10889483164747, (ITEM # BVMB710-F, Case UDI: 30889483164741); UDI-DI: 10889483164730, (ITEM # BVMB810, Case UDI: 30889483164734); UDI-DI: 10889483164716, (ITEM # BVMB810-F, Case UDI: 30889483164710); UDI-DI: 10889483164723, (ITEM # BVMB810S-F, Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
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