FDA Device recall Z-0430-2026
BD Alaris infusion Pump Module 8100, REF: 8100
- FDA Device
- Class I
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class I recall of BD Alaris infusion Pump Module 8100, REF: 8100 by Carefusion 303, citing if infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module fail….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0430-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
Reason
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Identifiers
| code_info | All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810…All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0430-2026%22
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