High FDA (Devices)·Z-0367-2024·Announced 2023-11-29

V-Care manual resuscitators recalled for CO2 rebreathing defect

SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a physical defect in a critical-care device that presents a direct risk of patient harm through CO2 rebreathing during resuscitation. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

SunMed Holdings, LLC is recalling Ventlab V-Care manual resuscitators in multiple configurations, including child, infant, pediatric, and small adult models. The recalled devices contain an integrated manometer that may have a backwards leak.

The backwards leak in the patient valve's integrated manometer can allow CO2 rebreathing. This defect may compromise the proper function of the resuscitator during use.

The recalled resuscitators were distributed nationwide across multiple U.S. states. All units manufactured from September 21, 2018 through present with the latest expiration date of October 11, 2028 are affected.

Healthcare facilities and clinicians using these devices should contact SunMed Holdings, LLC immediately for instructions on device return, replacement, or remediation.

The recalled product

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, V
Manufacturer: SunMed Holdings, LLC
Category: Medical Device — Respiratory / Resuscitation
Hazard: co2-rebreathing
backwards-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 9 recalled by SunMed Holdings, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · SunMed Holdings, LLC

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Same hazard · co2 rebreathing