Reported May 14, 2025 · Ongoing
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.…
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 HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope
7 of 7 products
| Model / number | Product as published |
|---|---|
2110 | NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB |
2110 | OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD |
2110 | NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW |
2110 | FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW |
2110 | OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA ¿ 21-2101-51 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA 21-2111-0401-78 PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA 21-2111-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA ¿ 21-2112-0400-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA ¿ 21-2111-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0401-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA ¿ 21-2111-0402-51 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA 21-2112-0402-78 PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA ¿ 21-2112-0402-51 PUMP KIT, CADD-SOLIS |
2110 | CE ENGLISH 1/EA ¿ 21-2111-0100-51 PUMP KIT, CADD-SOLIS, YELLOW |
2110 | 1/EA ¿ 21-2112-0100-51 |
- Lot codes and dates
- Affected CADD-Solis Software Versions
4.04.14.24.2.14.3
- UDI-DI
131 of 131 codes
4546027095675454602709568210610586034787106105860387781061058603878510610586038808106105860388221061058603923210610586041037106105860410511501951709969015019517101003150195171010101501951710103415019517101041150195171286971501951713534315019517154290150195171548871501951715492415019517154979150195171549861501951715499315019517155006150195171550131501951715504415019517246735150195172470081501951724716915019517247176150195172471831501951724720600610586038900006105860393100454602709562004546027095637045460270956440454602709566804546027095699045460270957050454602709571204546027095729045460270957360454602709589704546027095903045460270959100454602742298304546027424116045460274241300454602742414704546027424178045460274241850454602742419204546027424208045460274245980501951715493405019517155108106105860318541061058603295010610586033933
- Affected CADD-Solis Software Versions
- Amount recalled
- US: 83,833 items ; OUS: 71,843 items
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
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Using this product could cause serious injury, illness or death — stop using it now.
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