Class I — Ventlab Corporation
| Recalling firm | VENTLAB, LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Product | Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 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. |
| Quantity | 14,602 total for all units |
| Distribution | Nationwide Distribution including IL, OH, NY and TN. |
| Initiated | 2012-07-11 |
| Classified | 2012-11-01 |
| Terminated | 2013-06-30 |
| Recall number | Z-0172-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ventlab Corporation (Z-0172-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63347/
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