FDA recall Z-1662-2025

Smiths Medical ASD, Inc. · Class I · device

Product

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-04-10
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

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