Recall Z-1662-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-1662-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-04-10. It names one FDA 510(k) clearance: K170982. Product: CADD Solis HSPCA Pump. Reason: 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..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-04-10
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 moreSmiths Medical Ads, Inc.·cleared 2017-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.