Data Foundry

Medical device recalls 2020

Alaris Pump Module Model 8100 — Class II medical device recall Z-2822-2020

Ongoing recall by CareFusion 303, Inc., reported 2020-08-26, distributed nationwide. LED display, which provides infusion or patient monitoring values, on the module may have segments that appear

Recall numberZ-2822-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2020-06-30
Classified2020-08-19
Reported by FDA2020-08-26
DistributedNationwide (US)
Quantity1,442,097
Model numbers8100

Product

Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

Reason for recall

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

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-2822-2020. 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.