Recall Z-1668-2025 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21
| Date | May 7, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. |
| Root cause | Labeling design |
| Action | On April 10, 2025, the firm notified affected consignees via letters titled "Urgent Medical Device Correction." Customers were informed of conditions under which the false Upstream Occlusion Alarm may occur. The USO alarm can be cleared during these conditions by removing the administration from the pump, re-attaching the administration set, and restarting delivery. Customers should verify there is no upstream occlusion present. The firm will be making an update to the Infusion Pump Operator's Manual to include these conditions. |
| Quantity | 185,975 US; 127,701 OUS Total |
| Distribution | Worldwide - US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc., Feb 1, 2013 |