CADD Solis VIP Pump (Smiths Medical) – Thermal Damage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, PHARMGUA
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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 ;
Smiths Medical ASD, Inc. is recalling CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, due to There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION dated 4/10/25 was sent to customers. Actions for Users: Inform all affected CADD-Solis and CADD-Solis VIP users of this notice. Provide the instructions below: 1. Ensure all users or potential users of these products are immediately made aware of this notification. 2. Upon receipt of this notification and ongoing during regular maintenance, visually inspect the external condition of the battery pack or Wireless Communication Module and look for evidence of any physical damage. Handle a damaged device with caution. As stated in the battery pack Instructions for Use, if the battery pack housing is cracked or otherwise damaged, replace the battery pack. NEVER use a battery pack that appears damaged. A rechargeable battery pack must be replaced with either another CADD-Solis rechargeable battery pack or with 4 AA batteries. 3. Visually inspect the condition of the battery compartment for evidence of any physical damage. Contact Technical Support for repairs. 4. Always check the battery compartment for fluid or debris before inserting the batteries, and do not allow any fluid or debris to fall into the battery compartment. 5. Complete the electronic Response Form via the link provided within this email notification within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product. 6. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward your customer list to Sedgwick at icumedical3393@sedgwick.com. Sedgwick will notify customers with email addresses via email and will send physical notifications to customers without email addresses in order for them to complete the Response Form Follow up Actions by Smiths Medical: Smiths Medical is continuing to investigate this matter to determine if additional actions may be warranted. For further inquiries, please contact Smiths Medical using the following information: Smit
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026