Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

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.

Code information: All serial numbers for pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a. 3010, UDI/DI none, Serial Numbers: M03315, M03910; b. 3010A, UDI/DI 10610586032097, Serial Numbers: M04601, M05551, M05782, M06829, M07259, M07334, M07339, M07342, M07345, M07371, M08269, M08750, M08815, M10253, M10267, M10871, M10876, M10965, M11872, M11896, M11899, M11901, M11905, M11915; c. 3010E, UDI/DI none, Serial Numbers: M05179

Distribution pattern: Worldwide distribution.