Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
FDA Device Recall #Z-3140-2024 — Class II — August 15, 2024
Recall Summary
| Recall Number | Z-3140-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 15, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 303, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 180 |
Product Description
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Reason for Recall
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
Lot / Code Information
Model Number: 8300 UDI-DI codes: 10885403830020, 10885403830013 Serial Numbers: 16233040 16233078 16233149 16233080 16233328 16233293 16233308 16233153 16233320 16192058 16233232 16233330 16226112 16196835 16233159 16233363 16233362 16233226 16233163 16233069 16233074 16233077 16226102 16226107 16196802 16226103 16226099 16226113 16233296 16233101 16233211 16233223 16233203 16233302 16233360 16233359 16226098 16226109 16226106 16233361 16233285 16233141 16226110 16233145 16226105 16196832 16196755 16196594 16194385 16191983 16196603 16196615 16192142 16194384 16191988 16193961 16193955 16193991 16191985 16192001 16191939 16192287 16192936 16191995 16194400 16194370 16192010 16196608 16192493 16191991 16192008 16192002 16191976 16191998 16191993 16192012 16192966 16191971 16194376 16196806 16194399 16192927 16191911 16192004 16192006 16191997 16191979 16192967 16196596 16192094 16192724 16196818 16192728 16192758 16192862 16192720 16192804 16192850 16192789 16196591 16196612 16196599 16192126 16196587 16196592 16192111 16196588 16192717 16192685 16196867 16192715 16192698 16192125 16192490 16192702 16192144 16196790 16196793 16196797 16192734 16192878 16192772 16196877 16192899 16192763 16192014 16192841 16192870 16196862 16196590 16192755 16192096 16192731 16192886 16196619 16192930 16192737 16196796 16196595 16196606 16196593 16192811 16196811 16196743 16196821 16192109 16196589 16196627 16196786 16233137 16233128 16233315 16192282 16192395 16192162 16192016 16192435 16191982 16192181 16192183 16192370 16192221 16192371 16192398 16192350 16192352 16192015 16192061 16233124 16192013 16192384 16192382 16192434 16192218 16192202 16192442 16192201 16192460 16192443 16192163
Other Recalls from CareFusion 303, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX wit... | Feb 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1... | Dec 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis M... | Nov 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code:... | Nov 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100;... | Oct 17, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.