Reported Mar 22, 2017 · Terminated

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

Smiths Medical ASD, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD, Inc. · 1265 Grey Fox Rd · Saint Paul, MN · 55112-6929

Is this the product you have?

    • CADD Solis VIP Ambulatory Infusion Pump
    • Model 21-21210
    • Reorder 21-2120-0102-15
Lot codes and dates
    • 1071155
    • 1076826
    • 1081258
    • 1081260
    • 1081275
    • 1082475
    • 1082511
    • 1082512
    • 1090347
    • 1090348
    • 1090349
    • 1091767
    • 1091768
    • 1091769
    • 1091770
    • 1091771
    • 1092395
    • 1100186
    • 1100188
    • 1100189
Amount recalled
20

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 15, 2019 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.