Recall Z-1880-2016 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Ventlab LLC
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
| Date | Jun 1, 2016 (initiated Mar 15, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2430 |
| Distribution | Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA. |
| FDA record | Open on fda.gov |