Recall Z-3212-2026 · LHI Set, I.V. Fluid Transfer
ICU Medical, Inc.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600
| Date | Sep 17, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| Reason | Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus. |
| Root cause | Process control |
| Action | On August 20, 2026, the firm began notifying affected customers via Urgent Medical Device Correction letters. Customers were informed that certain reservoirs may exhibit fluid leakage at the joint between the connector and the tubing. Customers were instructed to check all inventory locations for affected product and discontinue use. All affected products should be destroyed following their institution's destruction process. If destruction is not immediately possible at your facility, quarantine the products until disposal. Customers should share the notification with all potential users of |
| Quantity | 185,688 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162219 | CADD® Infusion Disposables Portfolio with NRFit connectors Smiths Medical Asd, Inc., Jul 20, 2017 |