CADD-Solis Ambulatory Infusion Pumps — Class I medical device recall Z-2419-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2024-08-14. CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Ups
| Recall number | Z-2419-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-02-27 |
| Classified | 2024-08-02 |
| Reported by FDA | 2024-08-14 |
| Quantity | 9,284 units |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 10610586031854, 10610586032950, 10610586033933, 10610586033940, 10610586035357, 10610586035395, 10610586035401, 10610586035418, 10610586035425, 10610586035449, 10610586035456, 10610586035463, 10610586035487, 10610586035494, 10610586035531, 10610586035548, 30610586035337, 30610586035344, 30610586035368, 30610586035511, 30610586035528 |
| Serial numbers | 000688, 003574, 003836, 003839, 10006770, 1000681, 10012441, 1001701, 1001702, 1001703, 1001704, 1001705, 1001706, 1001707, 1001708, 1001709, 1001710, 1001711, 1001712, 1001713, 1001714, 1001715, 1001716, 1001717, 1001718 and 475 more |
| Model numbers | 21-21-1-0200-236, 2100 |
Product
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
Reason for recall
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2419-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.