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CADD recallZ-2523-2025 · ICU Medical Inc. · initiated Aug 6, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ICU Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2523-2025
Status
Open, Classified
Initiated by the company
Aug 6, 2025
Posted by the FDA
Sep 4, 2025
Recalling firm
ICU Medical Inc.
Quantity
265500 units
Product code
FPA
Distribution
Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97317).

Sources and updates

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