Class II U.S. Food and Drug Administration

CareFusion 303, Inc. BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 recall: Due to a number of modules flashed with a date and time associated

Recall published 9 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1217-2026
Published
February 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CareFusion 303, Inc.
Product type
Medical devices
Units affected
189 devices
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Number: 8100 Material Number: 8100BDBDXEN1212 UDI-DI code: 10885403810046 Equipment/Software Version: 8100BD PUMP MODULE V12.1.2 DOM V12.1.2 Serial Numbers: 17377484 17377907 17377935 17377939 17377942 17377946 17377948 17377952 17377959 17377961 17377965 17377970 17377972 17377973 17377976 17377978 17377980 17377987 17377992 17377993 17378071 17378072 17378073 17378074 17378075 17378079 17378081 17378082 17378084 17378085 17378086 17378087 17378088 17378089 17378090 17378091 17378092 17378093 17378094 17378095 17378096 17378098 17378099 17378101 17378102 17378103 17378124 17378125 17378126 17378127 17378145 17378147 17378149 17378153 17378154 17378156 17378157 17378158 17378163 17378164 17378166 17378167 17378168 17378170 17378172 17378176 17378178 17378179 17378180 17378181 17378182 17378183 17378184 17378185 17378186 17378187 17378188 17378189 17378190 17378193 17378194 17378196 17378198 17378199 17378201 17378203 17378205 17378207 17378209 17378221 17378222 17378223 17378224 17378225 17378226 17378227 17378236 17378239 17378240 17378241 17378242 17378243 17378244 17378245 17378246 17378247 17378248 17378249 17378267 17378268 17378269 17378270 17378271 17378272 17378279 17378281 17378282 17378286 17378287 17378288 17378289 17378290 17378293 17378296 17378298 17378303 17378305 17378309 17378310 17378312 17378314 17378315 17378316 17378317 17378318 17378319 17378320 17378321 17378333 17378334 17378335 17378336 17378337 17378338 17378339 17378347 17378349 17378363 17378364 17378365 17378366 17378367 17378369 17378370 17378371 17378375 17378377 17378395 17378396 17378401 17378402 17378403 17378405 17378408 17378424 17378433 17378434 17378435 17378444 17378445 17378447 17378449 17378452 17378454 17378455 17378465 17378466 17378467 17378481 17378482 17378483 17378484 17378485 17378497 17378499 17378502 17378503 17378505 17378506
UPC codes
10885403810046

Products covered by this recall

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 clinically accepted routes of administration: intravenous (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 following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10885403810046

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

CareFusion 303, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: CareFusion 303, Inc. — 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CareFusion 303, Inc. medical devices 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 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10885403810046. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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