STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with… — Class II medical device recall Z-1880-2016
Terminated recall by Ventlab LLC, reported 2016-06-08, distributed nationwide. Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple whe
| Recall number | Z-1880-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventlab LLC, Grand Rapids, MI, United States |
| Recall initiated | 2016-03-15 |
| Classified | 2016-06-01 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2016-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,430 |
| Lot numbers | 303320, 303400, 303523, 303612, 303791, 303833 |
| Model numbers | C8001B, C9001B, C9001C, C9001C-C |
Product
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
Reason for recall
Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1880-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.