Recall Z-1192-2023 ยท FRN Pump, Infusion
CareFusion 303, Inc.
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
| Date | Mar 1, 2023 (initiated Jan 24, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX Cardinal Health 303,Inc., Dec 28, 2007 |