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Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g… recallZ-1192-2023 · CareFusion 303, Inc. · initiated Jan 24, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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 root cause category: Software Design Change

What the company is doing

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, [email protected]; Technical Support, 1-866-488-1408, [email protected]; Clinical & Pharmacy Support, 1-858-617-1316, [email protected]; BD Designated Complaint Handling Unit, 1-888-812-3266, [email protected] Complete and return the customer response form to [email protected]

Recall details

Recall number
Z-1192-2023
Status
Open, Classified
Initiated by the company
Jan 24, 2023
Posted by the FDA
Mar 1, 2023
Recalling firm
CareFusion 303, Inc.
Quantity
83,185
Product code
FRN
FDA submissions
K072105
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

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K072105 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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