FDA Device recall Z-0173-2013
V*Care Resuscitator Infant Resuscitator, VN 3000 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 V*Care Resuscitator Infant Resuscitator, VN 3000 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-0173-2013 |
| 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
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 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 Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3…Product List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150. |
|---|
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-0173-2013%22
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