Smiths Medical ASD, Inc.: 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 V

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 items Lot/code info: 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 ;

UPC codes

15019517150292, 15019517150001, 15019517084368, 10610586042829, 15019517126587, 15019517096378, 15019517126600, 15019517149999, 15019517096392, 10610586042836, 15019517126617, 10610586042843, 15019517096385, 15019517126594

Source

Official record: FDA (Device enforcement) ↗

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