Agency classClass IOur severity:Severe FDA (Devices)·Z-0173-2013·Announced 2012-11-07

Ventlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage

Ventlab Corporation is recalling V*Care Infant Resuscitators due to a possible volume leakage through the inlet valve during compressions.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible volume leakage through the inlet valve during compressions of the resuscitator bag."

Plain-English summary

Ventlab Corporation is recalling specific lots of V*Care Resuscitator Infant Resuscitators, VN 3000 Series. The recall involves 14,602 units that were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee.

The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could affect the device's ability to provide proper respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

Healthcare facilities and consumers should stop using the affected units immediately. The specific product codes and lot numbers involved are VN3200MB (Lot #102032), VN3100MB-2 (Lot #102033), VN3100MBP (Lot #102046, 102182), VN3100MB-PW2 (Lot 3102050), and VN3100OB (Lot #102150).

The recalled product

Product: V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
Manufacturer: Ventlab Corporation
Category: Medical Device — Respiratory Support
Hazard: mechanical-defect
volume-leakage
Affected units: 14,602

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 (12)

Product List 071012
Product Codes: VN3200MB
Lot #102032
VN3100MB-2
Lot #102033
VN3100MBP
Lot #102046
102182
VN3100MB-PW2
Lot 3102050
VN3100OB
Lot #102150.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Ventlab Corporation 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 12 products in this recall →

Same manufacturer · Ventlab Corporation

See all →

Severe
Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07
Severe
Ventlab Infant Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
Severe
Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
FDA (Devices) · 2012-11-07
Severe
Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage
FDA (Devices) · 2012-11-07
Severe
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07

Same hazard · mechanical defect