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
| Model / number | Product as published |
|---|---|
21-2111-0402-51 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA |
21-2112-0402-51 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA |
21-2112-0100-51 | PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA |
21-2112-0300-01 | PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA |
21-2111-0300-01 | PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA |
21-2111-0401-51 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA |
21-2111-0100-51 | PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA |
21-2112-0401-51 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA |
21-2101-51 | PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA |
21-2111-0400-51 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA |
21-2111-0300-50 | PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA |
21-2101-00 | PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA |
21-2111-0300-00 | PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA |
21-2111-0402-78 | PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA |
21-2111-0100-00 | PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA |
21-2112-0300-00 | PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA |
21-2112-0402-78 | PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA |
21-2101-249 | PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA |
21-2111-0401-78 | PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA |
21-2102-51 | PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA |
- Lot codes and dates
- All serial numbers. 1 ) 21-2111-0402-51
- UDI-DI
150195171542902 ) 21-2112-0402-51
- UDI-DI
150195171549933 ) 21-2112-0100-51
- UDI-DI
106105860392327 ) 21-2111-0100-51
- UDI-DI
306105860392059 ) 21-2101-51
- UDI-DI
1061058603185413 ) 21-2111-0300-00
- UDI-DI
1061058603879214 ) 21-2111-0402-78
- UDI-DI
1501951715488715 ) 21-2111-0100-00
- UDI-DI
1061058603919516 ) 21-2112-0300-00
- UDI-DI
1061058603882217 ) 21-2112-0402-78
- UDI-DI
1501951715501318 ) 21-2101-249
- UDI-DI
1061058603478720 ) 21-2102-51
- UDI-DI
1061058603393322 ) 21-2111-0300-231
- UDI-DI
1061058603878523 ) 21-2112-0401-78
- UDI-DI
1501951710103424 ) 21-2112-0400-51
- UDI-DI
1061058604105125 ) 21-2112-0300-50
- UDI-DI
1061058603886026 ) 21-2111-0300-00
- UDI-DI
1061058603879227 ) 21-2111-0100-00
- UDI-DI
1061058603919528 ) 21-2111-0100-51
- UDI-DI
3061058603920529 ) 21-2111-0100-50
- UDI-DI
1061058603925630 ) 21-2101-51
- UDI-DI
1061058603185431 ) 21-2112-0100-50
- UDI-DI
1061058603927032 ) 21-2101-00
- UDI-DI
3501951715490433 ) 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.
Free recall alerts
Get alerted about new Smiths Medical ASD, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.