Class 2 Device Recall Alaris PC Unit

• Date Initiated by Firm: January 24, 2023
• Date Posted: March 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1192-2023
• Recall Event ID: 91582
• 510(K)Number: K072105
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
• Code Information: All PC Units, UDI-DI: 10885403801549, 10885403801532, with software versions 12.1.0, 12.1.2, 12.1.3, utilizing affected network cards and IP addresses
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed
• FDA Determined Cause: Software Design Change
• Action: On 01/24/23, notices were mailed to customers, who were told to do the following: 1) Inspect the back of the PC Unit and observe the wireless card. Wireless cards that protrude out of the PC Unit are impacted. 2) Software version can be seen on the PCU using the following steps: a) Press Options Key, b) Press Page Down soft key, c) Press Software Versions soft key to display Software Versions menu, d) Press View soft key for the PCU. To prevent this issue from occurring, do one of the following: 1. Exclude IP address ranges ending in x.x.x.224 to x.x.x.255 from all the DHCP scopes where the affected PC Units are being utilized. 2. Assign the affected PC Units IP addresses utilizing DHCP reservations to prevent the PC Unit from obtaining an IP address in the aforementioned range. 3. Assign the affected PC Units a static IP address outside of the aforementioned range. Actions for Clinical Users: Check if wireless icon is illuminated. If the PC Unit is not connected to the wireless network when using Interoperability, the clinical user can input all infusion parameters manually. In addition, the clinical end user can manually document the infusion in the EMR. Data sets can also manually be programmed or uploaded to the PC unit using a serial cable. Continue to rely on hospital established protocols for wireless downtime procedures. Customers who require additional assistance can contact: Customer Order Management, 1-800-482-4822, GMB-CTS-CustCareInfusion@bd.com; Technical Support, 1-866-488-1408, DL-US-INF-TechSupport@bd.com; Clinical & Pharmacy Support, 1-858-617-1316, GMB-AlarisMedSafetyProgram@bd.com; BD Designated Complaint Handling Unit, 1-888-812-3266, productcomplaints@bd.com Complete and return the customer response form to BDRC39@bd.com
• Quantity in Commerce: 83,185
• Distribution: US: FL, CA, OR, IL, WI, NJ, AZ, NV, CO, WY, NE, TX, MI, VA, OH, NC, LA, NM, AL, TN, AR, PA, CT, IN, KS, GA, SC, MD, UT, MA, DC, OK, IA, NY, WA, SD, ND, MN, KY, MO, WV, MS, DE, ME, MT, ID, NH, HI, AK, VT OUS: Canada, Qatar, Saudi Arabia,, Kuwait, United Arab Emirates, Israel, South Africa, Zimbabwe, Botswana, Australia, New Zealand
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FRN