FDA Device recall Z-0184-2024
BD Alaris PCU REF 8015
- FDA Device
- Class I
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class I recall of BD Alaris PCU REF 8015 by Carefusion 303, citing alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0184-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-15 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
BD Alaris PCU REF 8015
Reason
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Identifiers
| code_info | All Lots/ UDI DI: 10885403516030,10885403515316,10885403812033,10885403515286,10885403812026, 10885403515293,10885403494291,10885403515309,10885403812002 |
|---|
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-0184-2024%22
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