Reported Feb 4, 2026 · Ongoing
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a…
CareFusion 303, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
- BD Alaris"
- Pump Module model 8100 UDI-DI code10885403810046 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 clinically
- accepted routes of administrationintravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU)
- and one or more of the followingPump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications
- Lot codes and dates
- Catalog Number8100
- Material Number8100BDBDXEN1212
- UDI-DI code10885403810046
- Equipment/Software Version8100BD PUMP MODULE V12.1.2 DOM V12.1.2
- Serial Numbers
189 of 189 codes
173774841737790717377935173779391737794217377946173779481737795217377959173779611737796517377970173779721737797317377976173779781737798017377987173779921737799317378071173780721737807317378074173780751737807917378081173780821737808417378085173780861737808717378088173780891737809017378091173780921737809317378094173780951737809617378098173780991737810117378102173781031737812417378125173781261737812717378145173781471737814917378153173781541737815617378157173781581737816317378164
- Amount recalled
- 189 devices
Where it was sold
Why it was recalled
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
This product could cause temporary or reversible health problems — stop using it.
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