FDA Device recall Z-1309-2021
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad
- FDA Device
- Class I
- ongoing
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class I recall of BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad by Carefusion 303, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1309-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-03-03 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 303 |
| Distribution | US |
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
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
Identifiers
| code_info | Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad:…Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1309-2021%22
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