Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall establishes minimum Severe rating per rubric. No deaths or serious injuries reported in source material, preventing escalation to Critical.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific models of the CADD-Solis VIP ambulatory infusion pump due to an intermittent malfunction in the Air in Line Detector (AILD) function.
The AILD is designed to detect air in the infusion line and alert the clinician. Some affected pumps may fail to recognize air in the line and may not generate an alarm to notify the clinician. This malfunction could allow air to enter a patient's infusion line without triggering an alert to clinical staff.
This recall affects 642 units with specific model and serial numbers distributed to European countries including Belgium, Bahrain, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Italy, Netherlands, Norway, Portugal, and Sweden.
Patients and healthcare providers who have a CADD-Solis VIP pump should verify the model and serial number against the recall information and contact Smiths Medical for instructions on replacement or corrective action.
The recalled product
- Product
- CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- air-in-line-detection-failure
- alarm-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. 21-2120-0105-02L
- Serial Numbers: 1171502
- 1171536
- 1171537
- 1171538
- 1171539
- 1171540
- 1171541
- 1171542
- 1171543
- 1171544
- 1171545
- 1171546
- 1171547
- 1171548
- 1171549
- 1171550
- 1171551
- 1171552
- 1171553
Distribution
Distributed in 1 state:
- DE
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03