Recall Z-1681-2025 · MEA Pump, Infusion, Pca
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 ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/E
| Date | May 5, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 313,676 total units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad Smiths Medical Ads, Inc., Aug 24, 2017 |