FDA recall Z-1543-2024

Smiths Medical ASD Inc. · Class II · device

Product

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

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.

Key facts

Status
Ongoing
Initiation date
2023-12-19
Report date
2024-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2024