CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

FDA Device Recall #Z-1439-2017 — Class II — October 31, 2016

Recall Summary

Recall Number Z-1439-2017
Classification Class II — Moderate risk
Date Initiated October 31, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smiths Medical ASD, Inc.
Location Saint Paul, MN
Product Type Devices
Quantity 20

Product Description

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.

Distribution Pattern

Internationally to Finland

Lot / Code Information

1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.

Other Recalls from Smiths Medical ASD, Inc.

Recall # Classification Product Date
Z-1667-2025 Class I CADD-Solis HPCA Ambulatory Infusion Pump; Mode... Apr 10, 2025
Z-1681-2025 Class I CADD-Solis Infusion Pump Models: 1) PUMP KIT,... Apr 10, 2025
Z-1668-2025 Class I CADD-Solis VIP Ambulatory Infusion Pump; Mode... Apr 10, 2025
Z-1662-2025 Class I CADD Solis HSPCA Pump Apr 10, 2025
Z-1682-2025 Class I CADD Solis VIP Ambulatory Infusion Pump Models:... Apr 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.