CLASS I ONGOING Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
CareFusion Alaris PCA Module recalled by CareFusion 303
CareFusion 303 is recalling CareFusion Alaris PCA Module, distributed nationwide in the US. The recall was initiated on 4 Feb 2020 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1362-2020
- FDA event ID
- 84579
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Feb 2020
- FDA classified
- 5 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 Feb 2020 | Recall initiated by company | |
| 5 Mar 2020 | Classified by FDA | +30 days |
| 11 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CareFusion Alaris PCA Module, Model 8120
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is CareFusion Alaris PCA Module recalled?
Yes. CareFusion 303 recalled CareFusion Alaris PCA Module on 4 Feb 2020. The recall is Class I and its status is Ongoing. Recall number Z-1362-2020.
Why was it recalled?
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
Which lots are affected?
Software versions 12.1.0, and 9.33 and prior
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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