Z-1231-2025Class II

BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and...

Name: Z-1231-2025 BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and...
Creator: CareFusion 303, Inc.
Published: 2025-01-23
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-01-23 / Open, Classified

FDA source

CareFusion 303, Inc. began a recall of 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... on 2025-01-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1231-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-23
Posted: 2025-02-24
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
Product code: FRN Pump, Infusion
Reason for recall: 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.
FDA 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: [email protected] Contact Post Market Quality for Recall Questions at: Email : [email protected] Fax No.: 312-949-0576
Quantity in commerce: 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
Product codes and lots: Catalog Number: 8100 UDI-DI codes: 10885403810046 10885403517723 Software Version: 12.1.2 Serial/Lot Numbers: Pending

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1231-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1231-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-24

Product code FRN

K211218Class IIBD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. / cleared 2023-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)