—#215207

Product

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: ICU Medical Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2025-08-06
Posted by FDA: 2025-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.