Recall Z-1192-2023— CareFusion 303, Inc.

Name: FDA recall Z-1192-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-24

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2023-01-24. It names one FDA 510(k) clearance: K072105. 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. 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.

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-24
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072105 — ALARIS SYSTEM WITH MMS, MODEL 8XXXCardinal Health 303,Inc.·cleared 2007-12-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.