Reported Apr 24, 2024 · Ongoing
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Smiths Medical Model 3010 Syringe pumps
a. Protege Model 3010b. Medfusion Model 3010Ac. Protege UK Model 3010E
- Lot codes and dates
- 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
M03315M03910b. 3010AUDI/DI 10610586032097
- Serial Numbers
M04601M05551M05782M06829M07259M07334M07339M07342M07345M07371M08269M08750M08815M10253M10267M10871M10876M10965M11872M11896M11899M11901M11905M11915c. 3010EUDI/DI none
- Serial NumbersM05179
- Amount recalled
- 27 pumps
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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