Recall Z-2523-2025 ยท FPA Set, Administration, Intravascular
ICU Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
| Date | Sep 4, 2025 (initiated Aug 6, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| 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 I |
| Quantity | 265500 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.