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FDA (Device enforcement)Recalled 2025-04-10class i

Smiths Medical ASD, Inc.: CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE

Hazard

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

Details from the source

Reason for recall: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. Distribution: Worldwide - US Nationwide distribution. Quantity: 313,676 total units Lot/code info: 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-DI: 10610586041822 ;

UPC codes

15019517154290, 15019517154993, 10610586039232, 30610586039205, 10610586031854, 10610586038792, 15019517154887, 10610586039195, 10610586038822, 15019517155013, 10610586034787, 10610586033933, 10610586038785, 15019517101034, 10610586041051, 10610586038860, 10610586039256, 10610586039270, 35019517154904, 10610586041822

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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