CareFusion 303, Inc. Recall: CareFusion Alaris System, Alaris PC unit models 8000 and 8015
CareFusion 303, Inc. Recall: CareFusion Alaris System, Alaris PC unit models 8000 and 8015 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: CareFusion 303, Inc.; Product: CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518); Reason for recall: 1)Error 255-
| Recalling firm | CareFusion 303, Inc. |
|---|---|
| Product | 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 |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada |
| Recall initiated | 20200204 |
| Recall number | Z-1359-2020 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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