Reported Nov 29, 2023 · Ongoing

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.…

SunMed Holdings, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include

3 of 3 products

Products covered by this recall
#	Product as published
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.

Lot codes and dates: 11 of 11 products
Products covered by this recall
Model / number Barcodes Product as published
BVM510-F 1088948316426630889483184680 10889483164266, ( , Case UDI: 30889483184680)
BVMB710 1088948316475430889483164758 UDI-D: 10889483164754, ( , Case UDI: 30889483164758)
BVMB812 1088948316478530889483164789 UDI-DI: 10889483164785, ( , Case UDI: 30889483164789)
BVMB812-F 1088948316476130889483164765 UDI-DI: 10889483164761, ( , Case UDI: 30889483164765)
BVMB510-10 1088948316960530889483169609 UDI-DI: 10889483169605, ( , Case UDI: 30889483169609)
BVMB510-F 108894831646860889483164680 UDI-DI: 10889483164686, ( , Case UDI: 0889483164680)
BVMB510S-F 108894831646933088948316469 UDI-DI: 10889483164693, ( , Case UDI: 3088948316469)
BVMB710-F 1088948316474730889483164741 UDI-DI: 10889483164747, ( , Case UDI: 30889483164741)
BVMB810 1088948316473030889483164734 UDI-DI: 10889483164730, ( , Case UDI: 30889483164734)
BVMB810-F 1088948316471630889483164710 UDI-DI: 10889483164716, ( , Case UDI: 30889483164710)
BVMB810S-F 1088948316472330889483164727 UDI-DI: 10889483164723, ( , Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
Amount recalled: N/A

The agency filed one notice per product. You are reading one of them; the other 8 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Model / number	Barcodes	Product as published
`BVM510-F`	`1088948316426630889483184680`	10889483164266, ( , Case UDI: 30889483184680)
`BVMB710`	`1088948316475430889483164758`	UDI-D: 10889483164754, ( , Case UDI: 30889483164758)
`BVMB812`	`1088948316478530889483164789`	UDI-DI: 10889483164785, ( , Case UDI: 30889483164789)
`BVMB812-F`	`1088948316476130889483164765`	UDI-DI: 10889483164761, ( , Case UDI: 30889483164765)
`BVMB510-10`	`1088948316960530889483169609`	UDI-DI: 10889483169605, ( , Case UDI: 30889483169609)
`BVMB510-F`	`108894831646860889483164680`	UDI-DI: 10889483164686, ( , Case UDI: 0889483164680)
`BVMB510S-F`	`108894831646933088948316469`	UDI-DI: 10889483164693, ( , Case UDI: 3088948316469)
`BVMB710-F`	`1088948316474730889483164741`	UDI-DI: 10889483164747, ( , Case UDI: 30889483164741)
`BVMB810`	`1088948316473030889483164734`	UDI-DI: 10889483164730, ( , Case UDI: 30889483164734)
`BVMB810-F`	`1088948316471630889483164710`	UDI-DI: 10889483164716, ( , Case UDI: 30889483164710)
`BVMB810S-F`	`1088948316472330889483164727`	UDI-DI: 10889483164723, ( , Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.