FDA Device recall Z-0180-2013
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Dis…
- FDA Device
- Class I
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class I recall of AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Dis… by Ventlab, citing possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0180-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-07-11 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ventlab |
| Distribution | US |
Product
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.
Reason
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Identifiers
| code_info | Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0180-2013%22
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