NRFit recallZ-3212-2026 · ICU Medical, Inc. · initiated Aug 20, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
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.
FDA root cause category: Process control
What the company is doing
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 the reservoirs, and notify any accounts to whom the affected products have been further distributed. The firm will provide replacement products to affected customers upon receipt of a completed Customer Response Form to certify product destruction.
Recall details
- Recall number
- Z-3212-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 20, 2026
- Posted by the FDA
- Sep 17, 2026
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 185,688 units
- Product code
- LHI
- FDA submissions
- K162219
- 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.
Product description
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 21-7600-24 21-7600-24 21-7609-24
Code information (models, lots, serial numbers)
21-7600-24 UDI-DI 30610586044001 Lots 6026878 6037784 6054015 6062724 6070616 6082332 6092886 6101906 6108556 6126029 6140893 6143454 6147696 6147697 6162769 6155095 6166032 6171587 6171586 21-7609-24 UDI-DI 30610586044018 Lot 6022079 6037697 6037698 6053978 6061525 6072970 6072964 6070575 6077773 6092846 6101798 6108514 6108515 6108516 6140862 6140861 6140865 6155132
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- NRFit 21-7609-24Icu Medical, Inc. · Administrations sets with neuraxial connectors3 recalls484 reports
- NRFit 21-7600-24Icu Medical, Inc. · Administrations sets with neuraxial connectors4 recalls94 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K162219 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NRFit 21-7624-24Icu Medical, Inc. · Set, i.V. Fluid transfer2 recalls23 reports
- CADD 21-7649-24Icu Medical, Inc. · Administrations sets with neuraxial connectors2 recalls0 reports
- NRFit 21-7605-24Icu Medical, Inc. · Set, i.V. Fluid transfer28 reports
- NRFit 21-7608-24Icu Medical, Inc. · Administrations sets with neuraxial connectors10 reports
- NRFit 21-7664-24Icu Medical, Inc. · Set, i.V. Fluid transfer2 reports
- CADD 21-7665-24Icu Medical, Inc. · Administrations sets with neuraxial connectors1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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