CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Stat-Check Resuscitation Bag Manual Emergency Resuscitation recalled
Ventlab is recalling Stat-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas, distributed nationwide in the US. The recall was initiated on 15 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1880-2016
- FDA event ID
- 73766
- Recalling firm
- Ventlab, Grand Rapids, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2016
- FDA classified
- 1 Jun 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 15 Mar 2016 | Recall initiated by company | |
| 1 Jun 2016 | Classified by FDA | +78 days |
| 8 Jun 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.).
Where it was distributed
Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
Nationwide ArizonaCaliforniaFloridaMissouriMississippiNew YorkTexasWisconsin
Questions about this recall
Is Stat-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas recalled?
Yes. Ventlab recalled Stat-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas on 15 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1880-2016.
Why was it recalled?
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.
Which lots are affected?
Model SC9001B Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot numbers 303320 and 303612 Model SC9001C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask Lot number 303400 Model SC9001C-C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector Lot numbers 303523 and 303791 Model SC8001B Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot number 303833
Where was it sold?
Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ventlab
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000 recalled | Ventlab | Device Malfunction | Nationwide |
| Device | CLASS I | Premium Small Adult Resuscitator recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
| Device | CLASS I | Stat-Check Resuscitator, Adult Manual Emergency recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
| Device | CLASS I | Premium Small Child Resuscitator recalled by Ventlab | Ventlab | Packaging Defects | Nationwide |
| Device | CLASS I | AirFlow, Small Adult Resuscitator, AF5000 Series, Single use recalled | Ventlab | Packaging Defects | Nationwide |
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |