Reported May 14, 2025 · Ongoing

CADD-Solis Infusion Pump Models

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?

CADD-Solis Infusion Pump Models

33 of 33 products

Products covered by this recall
Model / numberProduct as published
21-2111-0402-51PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA
21-2112-0402-51PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA
21-2112-0100-51PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA
21-2112-0300-01PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA
21-2111-0300-01PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA
21-2111-0401-51PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA
21-2111-0100-51PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA
21-2112-0401-51PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA
21-2101-51PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA
21-2111-0400-51PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA
21-2111-0300-50PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA
21-2101-00PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA
21-2111-0300-00PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA
21-2111-0402-78PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA
21-2111-0100-00PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA
21-2112-0300-00PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA
21-2112-0402-78PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA
21-2101-249PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA
21-2111-0401-78PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA
21-2102-51PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA
Lot codes and dates
  • All serial numbers. 1 ) 21-2111-0402-51
  • UDI-DI
    • 15019517154290
    • 2 ) 21-2112-0402-51
  • UDI-DI
    • 15019517154993
    • 3 ) 21-2112-0100-51
  • UDI-DI
    • 10610586039232
    • 7 ) 21-2111-0100-51
  • UDI-DI
    • 30610586039205
    • 9 ) 21-2101-51
  • UDI-DI
    • 10610586031854
    • 13 ) 21-2111-0300-00
  • UDI-DI
    • 10610586038792
    • 14 ) 21-2111-0402-78
  • UDI-DI
    • 15019517154887
    • 15 ) 21-2111-0100-00
  • UDI-DI
    • 10610586039195
    • 16 ) 21-2112-0300-00
  • UDI-DI
    • 10610586038822
    • 17 ) 21-2112-0402-78
  • UDI-DI
    • 15019517155013
    • 18 ) 21-2101-249
  • UDI-DI
    • 10610586034787
    • 20 ) 21-2102-51
  • UDI-DI
    • 10610586033933
    • 22 ) 21-2111-0300-231
  • UDI-DI
    • 10610586038785
    • 23 ) 21-2112-0401-78
  • UDI-DI
    • 15019517101034
    • 24 ) 21-2112-0400-51
  • UDI-DI
    • 10610586041051
    • 25 ) 21-2112-0300-50
  • UDI-DI
    • 10610586038860
    • 26 ) 21-2111-0300-00
  • UDI-DI
    • 10610586038792
    • 27 ) 21-2111-0100-00
  • UDI-DI
    • 10610586039195
    • 28 ) 21-2111-0100-51
  • UDI-DI
    • 30610586039205
    • 29 ) 21-2111-0100-50
  • UDI-DI
    • 10610586039256
    • 30 ) 21-2101-51
  • UDI-DI
    • 10610586031854
    • 31 ) 21-2112-0100-50
  • UDI-DI
    • 10610586039270
    • 32 ) 21-2101-00
  • UDI-DI
    • 35019517154904
    • 33 ) 21-2112-0400-01
  • UDI-DI10610586041822
Amount recalled
313,676 total units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

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

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:56 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.