CareFusion Alaris PCA Module — Class I medical device recall Z-1362-2020
Ongoing recall by CareFusion 303, Inc., reported 2020-03-11, distributed nationwide. 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate
| Recall number | Z-1362-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2020-02-04 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ, TW, ZA |
| Quantity | 83,015 |
| Reason classes | software |
| Model numbers | 8120 |
Product
CareFusion Alaris PCA Module, Model 8120
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1362-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.