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U.S. Department of Health and Human Services

Class 2 Device Recall BD Alaris System Manager

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 Class 2 Device Recall BD Alaris System Managersee related information
Date Initiated by FirmMay 21, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2262-2024
Recall Event ID 94718
510(K)NumberK211218 
Product Classification Pump, infusion - Product Code FRN
ProductBD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Code Information UDI: 10885403960123/ Software versions 12.5.1
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactStephanie Chavez
858-336-8754
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce168 software version
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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