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.).
This recall has been terminated (originally issued June 1, 2016).
- Company
- Ventlab Llc
- Recall Initiated
- March 15, 2016
- Posted
- June 1, 2016
- Terminated
- November 1, 2016
- Recall Number
- Z-1880-2016
- Quantity
- 2430
- Firm Location
- Grand Rapids, MI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
Lot / Code Info
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
Root Cause
Process control
Action Taken
Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 2016, on March 15, 2016, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at PFA@ventlab.com.