Z-1192-2023Class II

Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from...

Name: Z-1192-2023 Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from...
Creator: CareFusion 303, Inc.
Published: 2023-01-24
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-01-24 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of 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 on 2023-01-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1192-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-24
Posted: 2023-03-01
Recalling firm: CareFusion 303, Inc
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
Product code: FRN Pump, Infusion
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
Root cause tag: software
FDA root 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, [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]
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1192-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1192-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code FRN

K072105Class IIAlaris System with Mms, Model 8XxxCardinal Health 303,Inc. / cleared 2007-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)