Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow sto...

FDA Recall #Z-2527-2025 — Class II — August 6, 2025

Recall #Z-2527-2025 Date: August 6, 2025 Classification: Class II Status: Ongoing

Product Description

Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24

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.

Recalling Firm

ICU Medical Inc. — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

15546 units

Distribution

Worldwide distribution.

Code Information

UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated