FDA Device recall Z-0176-2013
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is…
- FDA Device
- Class I
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class I recall of Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is… 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-0176-2013 |
| 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
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.
Reason
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Identifiers
| code_info | Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657. |
|---|
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-0176-2013%22
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