Recall Z-1359-2020— CareFusion 303, Inc.

Name: FDA recall Z-1359-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-04

Class I · Ongoing

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2020-02-04. It names one FDA 510(k) clearance: K133532. Product: CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518). Reason: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders.

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2020-02-04
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MXCarefusion 303, Inc.·cleared 2014-08-21

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

CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

Reason for recall

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

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