BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
FDA Device Recall #Z-2486-2024 — Class II — June 24, 2024
Recall Summary
| Recall Number | Z-2486-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 24, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 303, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 232 units |
Product Description
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
Reason for Recall
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Distribution Pattern
US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Lot / Code Information
UDI: 10885403512544/ Serial Number: 16170661 16210908 16089019 16062433 16147169 16080412 16124906 15940375 15940373 15940374 15940376 15957620 15957621 15941307 15967410 15967412 15967409 15967413 15967411 15967361 15943774 16056924 16188928 15943781 15943470 15943782 15872417 15902417 15902418 15888968 15253736 15253737 16247094 16283979 16225069 16222611 16165533 16205727 16270832 16200474 16244810 16250223 15935617 15654707 15654706 15489245 15723803 15927979 15924532 15569608 15832680 15832679 15824206 15815815 15815825 15415136 15415135 15415137 15415138 15622987 16174396 16193269 15939084 15939085 15854218 15854728 15854727 15398915 15383489 15489244 15489243 15606150 15606167 15924529 15888948 15924530 15924528 15569630 15575989 15575996 15575979 15575978 15575988 15575986 15575985 15569629 15575975 15587203 15587204 15587205 15824205 15824210 15824221 15815826 15815830 15852349 15852348 15353925 15353926 15422146 15422154 15422152 15422155 15422153 15422149 15422148 15422151 15422147 15422156 15422158 15422157 15939254 15939255 15783795 15783783 15853040 15398907 15398905 15398913 15666771 15226385 15227522 15204115 15204117 15550828 15550861 15929562 15929561 15929563 15930792 15930790 15930783 15930785 15930791 15930788 15930784 15930789 15930787 15930793 15929564 15930786 15645828 15645826 15645830 15248755 15248757 15248758 15282139 15282134 15295949 15353927 15353929 15353930 15282137 15257953 15282141 15260920 15920015 15920012 15920013 15921449 15921445 15921447 15921741 15921742 15921740 15921743 15363281 15923974 15923971 15923973 15923975 15923970 15923972 15504830 15504825 15504832 15504827 15504820 15504822 15504819 15504829 15504823 15639723 15639722 15639729 15933707 15933710 15933713 15933709 15933708 15933715 15933714 15933711 15933739 15935598 15935594 15935592 15935628 15935590 15935587 15935588 15935589 15935599 15935593 15935591 15935600 15935595 15935601 15935602 15935625 15935624 15743383 15600756 15600757 15441364 15441362 15441367 15441366 15442781 15442784 15442783 15442785 15786145 16102550 15328505 15398903 16160290 16051740 16151587 16143255 16143254
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
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.