Recall Z-2443-2019 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CareFusion 303, Inc.
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
| Date | Jul 1, 2019 |
| Status | Terminated |
| Reason | Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 |
| Root cause | Employee error |
| Action | On July 3, 2019, a "Medical Device Product Notification" letter was sent via FED Ex 2-day delivery with signature required. The letter informs consignees of the following: 1. Customers with the affected serial numbers should call the BD Support Center at 888-562-6018 to schedule service of the devices at the BD Service Depot. 2. BD will contact all affected facilities within 60 days to initiate the return process for the affected EtCO2 modules. BD will recalibrate the EtCO2 modules using a 5% CO2 gas concentration and send the devices back to the customer. 3. The US Food and Drug Adminis |
| Quantity | 76 EtCO2 units |
| Distribution | US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 Alaris Medical Systems, Inc., Feb 9, 2004 |