Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CADD Yellow Medication Cassette Reservoir with NRFit Connector

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CADD Yellow Medication Cassette Reservoir with NRFit Connectorsee related information
Date Initiated by FirmAugust 20, 2026
Date PostedSeptember 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3212-2026
Recall Event ID 99648
510(K)NumberK162219 
Product Classification Set, i.V. Fluid transfer - Product Code LHI
ProductCADD 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 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
FEI Number 3013319212
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
600 N Field Dr
Lake Forest IL 60045-4835
For Additional Information ContactCustomer Service
800-258-5361
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce185,688 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHI
-
-