CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Produc
Summary
The FDA issued a Class II for CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Cod by ICU Medical, Inc.. Reason: Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, unde.
Details
Source
Device Recall
External ID
Z-3212-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 185,688 units
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-20
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
ICU Medical, Inc. has 106 FDA actions in our database, including 96 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical, Inc. have FDA actions?
ICU Medical, Inc. has 106 FDA actions in our database, including 96 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3212-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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