BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad — Class I medical device recall Z-1309-2021
Ongoing recall by CareFusion 303, Inc., reported 2021-04-07, distributed nationwide. Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion,
| Recall number | Z-1309-2021 |
|---|---|
| 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 | 2021-03-03 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 160,300 |
| Model numbers | 49000239, 8100 |
Product
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Reason for recall
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
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-1309-2021. 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.