CLASS I Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
AirFlow, Infant Resuscitator, AF3000 Series, Single use recalled
Ventlab is recalling AirFlow, Infant Resuscitator, AF3000 Series, Single use, distributed nationwide in the US. The recall was initiated on 11 Jul 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0180-2013
- FDA event ID
- 63347
- Recalling firm
- Ventlab, Mocksville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Jul 2012
- FDA classified
- 1 Nov 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 11 Jul 2012 | Recall initiated by company | |
| 1 Nov 2012 | Classified by FDA | +113 days |
| 7 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AirFlow, Infant Resuscitator, AF3000 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 reversible apnea, commonly associated with cardiopulmonary arrest.
Where it was distributed
Nationwide Distribution including IL, OH, NY and TN.
Questions about this recall
Is AirFlow, Infant Resuscitator, AF3000 Series, Single use recalled?
Yes. Ventlab recalled AirFlow, Infant Resuscitator, AF3000 Series, Single use on 11 Jul 2012. The recall is Class I and its status is Terminated. Recall number Z-0180-2013.
Why was it recalled?
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Which lots are affected?
Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.
Where was it sold?
Nationwide Distribution including IL, OH, NY and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ventlab
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|---|---|---|---|---|---|
| Device | CLASS II | Stat-Check Resuscitation Bag Manual Emergency Resuscitation recalled | Ventlab | Other | Nationwide |
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| Device | CLASS I | Premium Small Adult Resuscitator recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
| Device | CLASS I | Stat-Check Resuscitator, Adult Manual Emergency recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
| Device | CLASS I | Premium Small Child Resuscitator recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
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| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
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