Recall Z-2522-2025— ICU Medical Inc.

Name: FDA recall Z-2522-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Class II · Ongoing

Class II FDA medical device recall by ICU Medical Inc., initiated 2025-08-06. It names one FDA 510(k) clearance: K040636. Product: Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24. Reason: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter..

Recalling firm: ICU Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-06
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K040636 — CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETSmiths Medical MD, Inc.·cleared 2004-05-19

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

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

Reason for recall

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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