CADD¿- Solis Ambulatory Infusion Pump — Class II medical device recall Z-1813-2015
Terminated recall by Smiths Medical ASD, Inc., reported 2015-06-24, distributed nationwide. Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly
| Recall number | Z-1813-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-05-26 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, FR, GB, HK, LB, NL, NZ, QA, SA, SE |
| Serial numbers | 1061043, 1061044, 1061045, 1061046, 1061047, 1061048, 1061049, 1061050, 1061051, 1061052, 1061053, 1061054, 1061055, 1061056, 1061057, 1061058, 1061059, 1061060, 1061061, 1061062, 1061063, 1061064, 1061065, 1061066, 1061067 and 475 more |
| Model numbers | 2111, 2112, 2120 |
Product
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
Reason for recall
Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some CADD¿-Solis pumps. Binding of the Cassette/ Keypad Lock can occur after latching the CADD¿-Solis Medication Cassette Reservoir or Administration Set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the Cassette/ Keypad Lock to the locked (e
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.