CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.
Summary
The FDA issued a Class I for CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically by Smiths Medical ASD, Inc.. Reason: Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of the.
Details
Source
Device Recall
External ID
Z-1662-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
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: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 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, MODEL 2110, CE ENGLISH 1/EA ¿ 21-2111-0100-51 PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA ¿ 21-2112-0100-51
Lot/Code Info: Affected CADD-Solis Software Versions: 4.0, 4.1, 4.2, 4.2.1, 4.3 UDI-DI: 4546027095675 4546027095682 10610586034787 10610586038778 10610586038785 10610586038808 10610586038822 10610586039232 10610586041037 10610586041051 15019517099690 15019517101003 15019517101010 15019517101034 15019517101041 15019517128697 15019517135343 15019517154290 15019517154887 15019517154924 15019517154979 15019517154986 15019517154993 15019517155006 15019517155013 15019517155044 15019517246735 15019517247008 15019517247169 15019517247176 15019517247183 15019517247206 00610586038900 00610586039310 04546027095620 04546027095637 04546027095644 04546027095668 04546027095699 04546027095705 04546027095712 04546027095729 04546027095736 04546027095897 04546027095903 04546027095910 04546027422983 04546027424116 04546027424130 04546027424147 04546027424178 04546027424185 04546027424192 04546027424208 04546027424598 05019517154934 05019517155108 10610586031854 10610586032950 10610586033933 10610586033940 10610586035357 10610586035395 10610586035401 10610586035418 10610586035432 10610586035456 10610586035494 10610586035548 10610586038792 10610586038839 10610586038860 10610586038891 10610586038914 10610586038921 10610586038938 10610586038952 10610586038969 10610586038983 10610586038990 10610586039010 10610586039041 10610586039065 10610586039072 10610586039089 10610586039195 10610586039256 10610586039270 10610586039409 10610586039416 10610586039430 10610586039447 10610586039454 10610586039461 10610586039478 10610586039485 10610586039492 10610586041822 30610586035337 30610586035344 30610586035368 30610586035511 30610586039205 30610586039397 35019517128677 35019517128684 35019517128691 35019517128721 35019517128738 35019517128745 35019517128769 35019517128783 35019517128837 35019517135316 35019517135323 35019517135330 35019517135354 35019517135361 35019517154850 35019517154867 35019517154874 35019517154904 35019517154911 35019517154942 35019517154959 35019517154966 35019517155055 35019517155062 35019517155079 35019517155086 35019517155130
Quantity Affected: US: 83,833 items ; OUS: 71,843 items
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-10
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD, Inc. have FDA actions?
Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1662-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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