CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR
FDA device recall Z-1667-2025 · posted 2025-05-07 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- MEA
- Quantity affected
- 185,975 US; 127,701 OUS Total
- Distribution
- Worldwide - US nationwide distribution.
- Date initiated
- 2025-04-10
- Date posted
- 2025-05-07
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (K170982) | Smiths Medical Ads, Inc. | 2017-08-24 |
| CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (K130394) | Smiths Medical Asd, Inc. | 2013-12-09 |
| CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144) | Smiths Medical MD, Inc. | 2008-03-07 |