CareFusion 303, Inc.: BD Alaris Pump Module REF 8100 The BD Alaris 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

Recall number

Z-1231-2025

Recalling firm

CareFusion 303, Inc.

Product

BD Alaris Pump Module REF 8100 The BD Alaris 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

Status

Open, Classified

Initiated

2025-01-23

Posted

2025-02-24

Terminated

not on file

Reason

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

Root cause

Under Investigation by firm

Action

On 01/23/2025, the firm sent via FedEx, 2-day mail and email an "URGENT MEDICAL DEVICE LABELING CORRECTION" Letter to customers informing them that Through an internal review, BD has identified that in the BD Alaris" System User Manual v 12.3.1 (p/n #P00000455), 12.3.2 (p/n# P00000827) and 12.4 (p/n# P00000828), there is an incorrect note on the Pump Module Set Loading instructions. The manuals incorrectly instruct users to leave the safety clamp in the open position when reloading an infusion set. The correct procedure is to leave the safety clamp in the closed position. Following the incorrect note could potentially disable a safety feature that could result in an accidental over-infusion if the roller clamp is left open. Customers are instructed to: 1. Post the Customer Notification on or near the affected systems as a reminder of the incorrect labeling issue until the Manual/Directions for Use (DFU) have been corrected. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form within 14 days, so that BD may acknowledge your receipt of this notification per FDA requirements and prioritize remediation scheduling. Actions BD is taking: 1. BD is in the process of updating the impacted user manuals. 2. BD will send customers follow-up notifications once the update of user manuals is completed. BD expects an updated user manual to be available by April 2025. For Questions or assistance: Contact - North American Regional Complaint Center for Product Complaints and Technical Questions at: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted. Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Contact Post Market Quality for Recall Questions at: Email : BDRC39@bd.com Fax No.: 312-949-0576

Quantity

242,098 systems

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: Canada

Lot, serial or model codes

Catalog Number: 8100 UDI-DI codes: 10885403810046 10885403517723 Software Version: 12.1.2 Serial/Lot Numbers: Pending

510(k) numbers

["K211218"]

PMA numbers

not on file

Product code

FRN

Firm FEI

2016493

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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