Agency classClass IOur severity:Severe FDA (Devices)·Z-0176-2013·Announced 2012-11-07

Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage

Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.

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 Safe Spot Infant Resuscitators, Pro-1900 Series, Single Patient Use. The recall involves 14,602 units distributed nationwide, including Illinois, Ohio, New York, and Tennessee. The affected product codes are PRO-1904 and PRO-1925, with specific lot numbers listed in the agency records.

The recall was initiated because of possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to provide adequate respiratory support to infants experiencing reversible apnea or cardiopulmonary arrest.

Healthcare facilities and consumers who have these specific units should stop using them immediately. Ventlab Corporation is the recalling firm responsible for managing the recall process.

The recalled product

Product: Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Manufacturer: Ventlab Corporation
Category: Medical Device — Respiratory Support
Hazard: device-malfunction
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 (10)

Product List 071012
Product Codes: PRO-1904
Lot #100155
100183
100451
100497
100655
101577 and PRO-1925
Lot #101550
101604101657.

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 V*Care Infant Resuscitator Recalled for Potential 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

Same hazard · device malfunction