FDA Device recall Z-2179-2025
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
- FDA Device
- Class I
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class I recall of BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions by Carefusion 303, citing infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2179-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-08 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Reason
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Identifiers
| code_info | BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Carefusion 303
- BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303 - BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
FDA Device · Class II · 2026-06-10 · Carefusion 303
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2179-2025%22
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