FDA Device recall Z-1543-2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 by Smiths Medical Asd, citing medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a mold….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1543-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-19 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Reason
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Identifiers
| code_info | Lot Numbers: P0407365, P0486670, P0561740 |
|---|
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-1543-2024%22
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