FDA-Device2024-04-24Class II
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Smiths Medical ASD Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1842 guide barrel clamps
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2024Don't want to check this manually?
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