FDA Device recall Z-2421-2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial…
- FDA Device
- Class I
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class I recall of CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial… by Smiths Medical Asd, citing the CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2421-2024 |
| 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 VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) 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
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
Identifiers
| code_info | REF List Number 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI…REF List Number 21-2120-0100-02, UDI/DI 10610586040429, Serial Numbers: 1033919; REF List Number 21-2120-0100-03, UDI/DI 30610586040430, Serial Numbers: 1024307, 1024333, 1025299, 1027869, 1027794; REF List Number 21-2120-0100-50, UDI/DI 10610586038501, Serial Numbers: 1015104, 1032637, 1019622, 1019666, 1019677, 1019718, 1019720, 1019790, 1019795, 1019806, 1019812, 1019907, 1020978, 1020984, 1021003, 1021146, 1021160, 1021161, 1021229, 1021237, 1021271, 1021285, 1011594, 1011601, 1011616, 1011618, 1011638, 1011640, 1012715, 1012721, 1012726, 1012736, 1021319, 1021382, 1021393, 1023095, 1026455, 1026662, 1026793, 1027760, 1031023, 1031026, 1031696, 1032360, 1032375, 1032377, 1032381, 1032556, 1032560, 1032568, 1032569, 1032570, 1032578, 1032607, 1032633, 1034367, 1034394, 1034411, 1034412, 1034424, 1035087, 1035088, 1035103, 1035105, 1035116, 1032362, 1034083, 1035086, 1128327, 1021322, 1026791, 1034390; REF List Number 21-2120-0102-02, UDI/DI 10610586042591, Serial Numbers: 107 |
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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-2421-2024%22
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