PlainRecalls
FDA Devices Critical Class I Ongoing

CADD Solis HSPCA Pump

Reported: May 14, 2025 Initiated: April 10, 2025 #Z-1662-2025

Product Description

CADD Solis HSPCA Pump

Reason for Recall

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.

Details

Recalling Firm
Smiths Medical ASD, Inc.
Units Affected
US: 83,833 items ; OUS: 71,843 items
Distribution
Worldwide - US Nationwide distribution.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
CADD Solis HSPCA Pump. Recalled by Smiths Medical ASD, Inc.. Units affected: US: 83,833 items ; OUS: 71,843 items.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1662-2025.