FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
- Recall number
- Z-2262-2024
- Recalling firm
- CareFusion 303, Inc.
- Product
- BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
- Status
- Open, Classified
- Initiated
- 2024-05-21
- Posted
- 2024-07-03
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- UDI: 10885403960123/ Software versions 12.5.1
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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