FDA-Device2025-05-14Class I

CADD Solis HSPCA Pump

Smiths Medical ASD, Inc.
Hazard

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Sold states
Worldwide - US Nationwide distribution.
Affected count
US: 83,833 items ; OUS: 71,843 items
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
CADD Solis HSPCA Pump

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1662-2025

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