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 3010
    • b. Medfusion Model 3010A
    • c. 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
    • 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 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.

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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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.