CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could interrupt patient therapy or monitoring, representing a risk of harm where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris System PC Unit Model 8000 modular infusion pump and monitoring system. The recall involves 37,141 units distributed across the United States and various international locations.
The recall is due to a potential issue where one or more screws or washers may be loose or missing. This can cause the battery to not be properly secured to the PC Unit. If the system is running on battery power, this condition may result in a power loss accompanied by a prolonged, non-silenceable alarm. Such a power loss may lead to an interruption of patient therapy or monitoring.
Healthcare facilities and users should check their devices for loose or missing screws or washers securing the battery. If the issue is present, the device should be taken out of service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 37,141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CareFusion 303, Inc.
See all →- HighBD Pyxis MedBank Mini fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedStation ES fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Anesthesia Station fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedBank Tower fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Mini Main cabinets may overheat at fingerprint scanner
FDA (Devices) · 2026-06-10
Same hazard · power loss
See all →- HighHumidifier devices recalled because power loss alert sounds under two minutes
FDA (Devices) · 2025-10-22
- HighBD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA (Devices) · 2025-03-05
- HighBronchoscopic system may lose power due to defective component
FDA (Devices) · 2024-12-25
- High2025 Polestar 3 Vehicles High to Low Voltage Converter Damage Recall
NHTSA · 2024-12-18
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27