Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CADD Solis VIP Ambulatory Infusion Pump Recalled by Smiths Medical ASD, Inc. Due to 20 Pumps sold to the Finnish market contain...

Date: October 31, 2016
Company: Smiths Medical ASD, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.

Affected Products

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

Quantity: 20

Why Was This Recalled?

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.

Where Was This Sold?

Internationally to Finland

About Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report