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.
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- April 10, 2025
- Posted
- May 5, 2025
- Recall Number
- Z-1682-2025
- Quantity
- 313,676 items
- Firm Location
- Minneapolis, MN
Reason for Recall
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Distribution
Worldwide - US Nationwide distribution.
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 ;
Root Cause
Under Investigation by firm
Action Taken
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