CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, 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 FDA has classified this as a Class I recall. The source text explicitly states the malfunction can lead to serious patient injury or death, meeting the Critical severity threshold per the rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD-Solis HPCA Ambulatory Infusion Pumps and CADD-Solis VIP models. The 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. The recall affects 185,975 units distributed in the US and 127,701 units distributed outside the US. Patients using these pumps should contact their healthcare provider immediately to discuss the issue and next steps regarding their infusion therapy.
Affected models and part numbers have been identified by UDI-DI codes. Healthcare providers and patients who have received these pumps should stop using them and return them to the manufacturer or their supplier for inspection or replacement.
The recalled product
- Product
- CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP…
- Manufacturer
- Smiths Medical ASD, Inc.
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.
See all 2 products in this recall →Related recalls
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