Infusion pump modules recalled over a daylight saving timestamp fault
CareFusion is recalling 189 BD Alaris Pump Modules, model 8100, because modules flashed with a daylight saving time timestamp may lose connectivity to hospital networks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is loss of network connectivity, with no patient harm or reported injury.
Plain-English summary
The BD Alaris Pump Module model 8100, UDI-DI 10885403810046, is being recalled by CareFusion 303, Inc. The record describes the BD Alaris System with Guardrails Suite MX as a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric and neonatal patients.
The reason given in the enforcement record is a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause a connectivity issue with hospital networks. The record states this issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PC Unit to the hospital network.
The record lists 189 devices under catalog number 8100, material number 8100BDBDXEN1212, with equipment/software version and serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, in Arizona, Indiana, Ohio and Virginia. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is a network connectivity issue, and no injuries are reported. Facilities should follow the firm's instructions.
The recalled product
- Product
- BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clini
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion pump
- Affected units
- 189
Distribution
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