Recall Z-1662-2025 · MEA Pump, Infusion, Pca
Smiths Medical ASD, Inc.
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/
| Date | May 7, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. |
| Root cause | Software design |
| Action | Firm began notifying customers on April 10, 2025 via letters titled "Urgent Medical Device Correction." Customers were instructed to validate any wireless network changes or updates to hospital network settings with the pump/communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment. If the alarm recurs or is unable to be cleared by power cycling the pump, the customer should revert to prior compatible network settings or turn off the wireless function of the communication module. The firm will al |
| Quantity | US: 83,833 items ; OUS: 71,843 items |
| 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 |