FDA Device recall Z-0172-2013
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufacture…
- FDA Device
- Class I
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class I recall of Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufacture… 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-0172-2013 |
| 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
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.
Reason
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Identifiers
| code_info | Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193. |
|---|
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-0172-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.