Reported Dec 18, 2019 · Terminated

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The…

Smiths Medical ASD Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

  • Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
Lot codes and dates
  • Serial numbers

    627 of 627 codes

    • 2039045
    • 2039062
    • 2039082
    • 2039084
    • 2039093
    • 2039122
    • 2039128
    • 2039132
    • 2039133
    • 2039137
    • 2039145
    • 2039151
    • 2039153
    • 2039158
    • 2039164
    • 2039174
    • 2039178
    • 2039181
    • 2039182
    • 2039183
    • 2039187
    • 2039202
    • 2039203
    • 2039204
    • 2039208
    • 2039209
    • 2039210
    • 2039211
    • 2039212
    • 2039216
    • 2039217
    • 2039220
    • 2039221
    • 2039223
    • 2039225
    • 2039226
    • 2039228
    • 2039231
    • 2039232
    • 2039234
    • 2039235
    • 2039236
    • 2039238
    • 2039239
    • 2039246
    • 2039247
    • 2039248
    • 2039250
    • 2039252
    • 2039259
    • 2039290
    • 2039291
    • 2039292
    • 2039295
    • 2039305
    • 2039307
    • 2039308
    • 2039312
    • 2039313
    • 2039315
Amount recalled
626 devices

Where it was sold

Why it was recalled

Stop using this product now

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 6, 2024 · Data as of Sep 19, 5:28 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.