CADD Solis VIP Ambulatory Infusion Pump — Class II medical device recall Z-1439-2017
Terminated recall by Smiths Medical ASD, Inc., reported 2017-03-22. 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When
| Recall number | Z-1439-2017 |
|---|---|
| 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 | 2016-10-31 |
| Classified | 2017-03-10 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2019-07-15 |
| Countries outside the US | FI |
| Quantity | 20 |
| Model numbers | 21-21210 |
Product
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Reason for recall
20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1439-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.