FDA Device recall Z-2419-2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100

FDA Device
Class I
ongoing
Published 2024-08-14

On 2024-08-14 the FDA classified a Class I recall of CADD-Solis Ambulatory Infusion Pumps, Model 2100 by Smiths Medical Asd, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2419-2024
Classification	Class I
Status	ongoing
Initiated	2024-02-27
Published	2024-08-14
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	n/a

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

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.

Identifiers

code_info	REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405,… REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1

code_info

REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405,…

REF List Number: 21-2101-0200-02; UDI/DI 30610586035337, Serial Numbers: 1006964, 1006966, 1006969, 1008404, 1008405, 1009451, 1010631, 1014398, 1010689, 1010420, 1010442, 1010443, 1010444, 1010445, 1005368, 1005365, 1006283, 1006298, 1008409, 1009427, 1009428, 1009429, 1009431, 1009433, 1010419, 1011448, 1011450, 1011451, 1011452, 1006964, 1006966, 1008404, 1009451, 1011447, 1011449, 1010432, 1009715; REF List Number: 21-2101-00; UDI/DI 10610586032950, Serial Numbers: 1002001, 1002001, 1002006, 1002009, 1002010, 1002014, 1002016, 1002017, 1002018, 1002023, 1002025, 1002026, 1002028, 1002031, 1002033, 1002034, 1002036, 1002037, 1002039, 1002040, 1002041, 1002042, 1002043, 1002045, 1002051, 1002053, 1002054, 1002055, 1002058, 1002059, 1002060, 1002063, 1002064, 1002065, 1002067, 1002068, 1002070, 1002072, 1002074, 1002077, 1002078, 1002081, 1002082, 1002085, 1002086, 1002088, 1002090, 1002094, 1002095, 1002097, 1002101, 1002103, 1002105, 1002106, 1002107, 1002108, 1002109, 1002110, 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2419-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.