Class 2 Device Recall BD Alaris" Pump Module model 8100

• Date Initiated by Firm: November 06, 2025
• Date Posted: January 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1217-2026
• Recall Event ID: 97871
• 510(K)Number: K211218
• Product Classification: Pump, infusion - Product Code FRN
• 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 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.
• Code Information: 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
• FEI Number: 2016493
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: Stephanie Chavez; 858-336-8754
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: On 11/06/2025, the firm sent via mail and email an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter informing customers that during an electronic medical record interoperability workflow, a BD Alaris" PCU (Point of Care Unit) connected to an affected BD Alaris" Pump Module may disconnect from the hospital network. The connectivity issue relates to an unrecognized date and time ( datetime ) stored within the affected BD Alaris" Pump Module software. The software that was loaded onto the affected pump modules has a datetime that falls within the Daylight Savings Time (DST) adjustment. The Alaris" System Manager software that mediates connectivity between the PCU module and the hospital network does not recognize this DST datetime as valid, resulting in loss of connectivity between the PCU module and the network. Instructions to Clinicians: 1. If an affected Pump Module is being used in bi-directional interoperative workflows, return it to Biomedical Engineering when clinically feasible. 2. No immediate action is required if the facility does not utilize bi-directional interoperative workflows. In such cases, the affected Pump Module should be returned to Biomedical Engineering when not in use. Instructions for Customers and Distributors: 1. Locate the affected devices identified in Attachment A and return to Biomedical Engineering for re-flashing. 2. Complete the attached Customer Response Form and return it to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 3. Please contact the BD Recall Support Center to coordinate self-remediation or depot-based remediation. If performing self-remediation, the Support Center will provide a tracking form to document completion back to BD. Alternatively, customers may return their affected devices to be serviced by the BD Service Center. For Questions - contact Recall Support Center Phone: 1-888-562-6018 Phone Hours: 7:00am to 4:00pm PT, Monday- Friday Email: SupportCenter@bd.com
• Quantity in Commerce: 189 devices
• Distribution: U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN