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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84579

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 04, 2020
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
CareFusion 303, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1359-2020
Recall number
Z-1359-2020
Initiated
February 04, 2020
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
870070

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Model 8000, software versions 9.5 and prior; Model 8015, software versions 12.1.0, and 9.33 and prior

Distribution pattern

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, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.

device · product 2 of 4

CareFusion Alaris Pump Module, Model 8100

Z-1360-2020
Recall number
Z-1360-2020
Initiated
February 04, 2020
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
1286898

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Software versions 12.1.0, and 9.33 and prior

Distribution pattern

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, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.

device · product 3 of 4

CareFusion Alaris Syringe Module, Model 8110

Z-1361-2020
Recall number
Z-1361-2020
Initiated
February 04, 2020
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
114835

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Software versions 12.1.0, and 9.33 and prior

Distribution pattern

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, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.

device · product 4 of 4

CareFusion Alaris PCA Module, Model 8120

Z-1362-2020
Recall number
Z-1362-2020
Initiated
February 04, 2020
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
83015

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Software versions 12.1.0, and 9.33 and prior

Distribution pattern

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, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.