FDADecember 19, 2023device

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

smiths medical asdsmithssmiths medical

UPCs

4000010124910610586040078106105860400541061058604081840000105249106105860435811061058604356710610586043574150195170707501501951706962440000106231

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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