FDA Device recall Z-0175-2013
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 2…
- FDA Device
- Class I
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class I recall of AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 2… 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-0175-2013 |
| 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 Resuscitator, Adult Resuscitator, AF1000 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 List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot…Product List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666. |
|---|
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-0175-2013%22
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