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U.S. Department of Health and Human Services

Class 2 Device Recall ChemoLock Extension Set

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 Class 2 Device Recall ChemoLock Extension Setsee related information
Date Initiated by FirmMarch 24, 2026
Date PostedMay 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2210-2026
Recall Event ID 98622
510(K)NumberK131549 
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
ProductOncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Code Information UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
FEI Number 2025816
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer Reason
for Recall		Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
FDA Determined
Cause 2		Process control
ActionOn 3/24/2026, correction notices were emailed to customers who were asked to do the following: 1) Discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the attached Customer Response Form to marketaction@mailac.custhelp.com For further inquiries, please contact firm: Global Complaint Management, globalcomplaints@icumed.com, 1-866-216-8806. Customer Service, customerservice@icumed.com, 1-800-258-5361. Field Service Processing, marketaction@mailac.custhelp.com
Quantity in Commerce20,506
DistributionUS Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.
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 = ONB
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