FDA Device recall Z-2718-2020
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
- FDA Device
- Class I
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class I recall of Alaris Pump Module Model 8100, a modular infusion pump and monitoring system by Carefusion 303, citing cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2718-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-06-30 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Reason
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.
Identifiers
| code_info | During cleaning, updated cleaning instructions and IUI covers must be used for all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2718-2020%22
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