BD Alaris System Manager REF: 9601, compatible with BD… recallZ-2262-2024 · CareFusion 303, Inc. · initiated May 21, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2262-2024
- Status
- Open, Classified
- Initiated by the company
- May 21, 2024
- Posted by the FDA
- Jul 3, 2024
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 168 software version
- Product code
- FRN
- FDA submissions
- K211218
- 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 description
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Code information (models, lots, serial numbers)
UDI: 10885403960123/ Software versions 12.5.1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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