CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states that interruption or delay of therapy can lead to serious patient injury or death. FDA has classified this as Class I. Per the rubric, the risk of death qualifies for a Critical (5) score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD-Solis VIP Ambulatory Infusion Pumps (multiple model numbers) due to a defect where the pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions.
When the false alarm occurs, it interrupts the active infusion of medication. Any interruption or delay of therapy can lead to serious patient injury or death, particularly for patients dependent on continuous infusions for critical conditions.
The pumps affected are distributed nationwide in the US and worldwide. Patients or healthcare providers using these pumps should contact Smiths Medical immediately for instructions on whether the pump should be discontinued or for guidance on next steps. Healthcare facilities should also review their inventory and patient usage records for affected model numbers.
The recalled product
- Product
- 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…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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