FDA Device recall Z-0185-2024
BD Alaris Syringe Module, REF 8110
- FDA Device
- Class I
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class I recall of BD Alaris Syringe Module, REF 8110 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-0185-2024 |
| 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 Syringe Module, REF 8110
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:10885403516047, 10885403515323, 10885403811043, 10885403515255 10885403811036, 10885403515262, 10885403811012, 10885403515279, 10885403424267 |
|---|
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-0185-2024%22
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