Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

Recall date

October 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1439-2017

FDA classification

Class II

Brand / firm

Smiths Medical ASD, Inc.

Sold / distributed

Internationally to Finland

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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