Z-2262-2024Class II

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Name: Z-2262-2024 BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Creator: CareFusion 303, Inc.
Published: 2024-05-21
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2024-05-21 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units on 2024-05-21. FDA classified it as Class II and gives the reason as "Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2262-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-21
Posted: 2024-07-03
Recalling firm: CareFusion 303, Inc
Product: BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Product code: FRN Pump, Infusion
Reason for recall: Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On August 22, 2024 a subsidiary of Becton, Dickinson and Company (BD) issued a second "Urgent Medical Device Correction" notification via FedEx and E-Mail to new consignees as well as consignees that previously received the 1st recall notification on June 3, 2024. BD asked consignees to take the following actions: 1. If the PCU is connected to the Server, no further actions are necessary, and PCU will function as intended. 2. If the PCU loses connection to the Server, the wireless network indicator icon on the PCU will be in an OFF state (not illuminated), and the PCU can continue to be used. See scenarios below for next steps. a. Non-interoperability customers: The pump programming workflow does not change. If the PCU does not have the expected Data Set, the clinical end user can utilize manual programming as described in the BD Alaris" System with Guardrails" Suite MX User Manual. In addition, a new Data Set can be uploaded to the PCU using a serial cable (per BD Alaris" System Maintenance User Manual v12.5 or BD Alaris" Guardrails" Editor User Manual). b. Interoperability customers: The clinical end user should follow established Interoperability downtime procedures and manually program the infusion as stated in the BD Alaris" System with Guardrails" Suite MX User Manual. Manual programming includes normal access to the BD Alaris Guardrails" dose error reduction software (DERS) and configurations. In addition, the clinical end user can manually document the infusion in the Electronic Medical Record (EMR). 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.
Quantity in commerce: 168 software version
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI.
Product codes and lots: UDI: 10885403960123/ Software versions 12.5.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2262-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2262-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

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)