FDAFDA · Food and drugs·Recall number Z-1682-2025
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231; 12) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249; 13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-249; 14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01; 15) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.
Published May 14, 2025 · Recall initiated: April 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- All serial numbers. 1 ) 21-2127-0105-01 , UDI-DI: 15019517150292 ; 2 ) 21-2120-0105-01 , UDI-DI: 15019517150001 ; 3 ) 21-2120-0103-01 , UDI-DI: 15019517084368 ; 4 ) 21-2120-0102-51 , UDI-DI: 10610586042829 ; 5 ) 21-2120-0104-01 , UDI-DI: 15019517126587 ; 6 ) 21-2120-0103-51 , UDI-DI: 15019517096378 ; 7 ) 21-2127-0104-01 , UDI-DI: 15019517126600 ; 8 ) 21-2120-0105-00 , UDI-DI: 15019517149999 ; 9 ) 21-2120-0103-78 , UDI-DI: 15019517096392 ; 10 ) 21-2120-0102-78 , UDI-DI: 10610586042836 ; 11 ) 21-2120-0104-231 , UDI-DI: 15019517126617 ; 12 ) 21-2120-0102-249 , UDI-DI: 10610586042843 ; 13 ) 21-2120-0103-249 , UDI-DI: 15019517096385 ; 14 ) 21-2125-0104-01 , UDI-DI: 15019517126594 ; 15 ) 21-2120-0102-249 , UDI-DI: 10610586042843 ;
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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