ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with flow stop

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.

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 ICUMedical8176@sedgwick.com 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 ICUMedical8176@sedgwick.com. For further inquires: - To report adverse events or product complaints: Global Complaint Management: productcomplaints@icumed.com; 1-(866)-216-8806 - Additional information or to request replacement product: Customer Service: customerservice@icumed.com; 1-(800)-258-5361 - Questions about this communication: Field Action Processing: ICUMedical8176@sedgwick.com; 1-(844)-861-6220

• FDA enforcement recordOfficial FDA database entry for Z-2526-2025
• FDA device classification · FPAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ICU Medical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.