Class II

Medical Device Recall: Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Smiths Medical ASD Inc. · December 19, 2023

Reason for Recall

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.

Distribution

Worldwide distribution.

Quantity Affected

1842 guide barrel clamps

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1543-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Smiths Medical ASD Inc. Medical Device Recall: Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 | SafeCheck