BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-2527-2025 · Initiated August 6, 2025

    Recall

    Recall Number
    Z-2527-2025
    Event Number
    97317
    Firm
    ICU Medical Inc.
    FEI Number
    3012307300
    Product Code
    FPA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 6, 2025
    Posted
    September 4, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    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

    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.

    Action

    ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 08/06/2025 via registered mail and email. The notice explained the issue, potential risk can requested the following: Customer Required Actions: Please complete the following actions below. 1. Review your inventory of CADD Medication Cassette Reservoirs to confirm if any of the affected lots are within your possession. 2. Quarantine the affected product and destroy or discard it immediately following your institution s process for destruction or discarding. 3. Return the attached Customer Response Form to [email protected] within ten (10) days of receipt to acknowledge your understanding of this notification. 4. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. Request that they complete the Customer Response Form and return it to [email protected]. For further inquires: - To report adverse events or product complaints: Global Complaint Management: [email protected]; 1-(866)-216-8806 - Additional information or to request replacement product: Customer Service: [email protected]; 1-(800)-258-5361 - Questions about this communication: Field Action Processing: [email protected]; 1-(844)-861-6220

    Distribution

    Worldwide distribution.

    Quantity

    15546 units