FDA Device recall Z-0186-2024
Alaris PCA Module 8120
- FDA Device
- Class I
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class I recall of Alaris PCA Module 8120 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-0186-2024 |
| 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
Alaris PCA Module 8120
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: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518 |
|---|
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-0186-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.