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U.S. Department of Health and Human Services

Class 1 Device Recall BD Alaris Systems Manager

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 Class 1 Device Recall BD Alaris Systems Managersee related information
Date Initiated by FirmFebruary 18, 2025
Date PostedMarch 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1304-2025
Recall Event ID 96323
510(K)NumberK211218 
Product Classification Infusion safety management software - Product Code PHC
ProductBD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Code Information Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3) UDIs: 10885403960123 10885403519666 (10885403960116)
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactBD Recall Support Center
888-562-6018
Manufacturer Reason
for Recall		Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 18, 2025, Becton, Dickinson issued a " Urgent Medical Device Product Correction" Notification. to affected consignees via Fed-Ex and E-Mail. 1. Users should review all infusion parameters pre-populated and confirm they are correct before pressing START as stated in the BD Alaris User Manual. 2. Disseminate this notice within your facility network to ensure that all concerned personnel are made aware of this issue. 3. BD Project Managers will engage with you to address any questions regarding this notice, and specific next steps for your facility. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form, regardless of whether you have any of the impacted material. This will allow BD to confirm receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
DistributionUS: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI OUS: None
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 = PHC
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