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 PumpModel 21-21210Reorder 21-2120-0102-15
- Lot codes and dates
10711551076826108125810812601081275108247510825111082512109034710903481090349109176710917681091769109177010917711092395110018611001881100189
- 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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