ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
UDI:10887709071398/Lot:14397348, 14377757
Products Sold
UDI:10887709071398/Lot:14397348, 14377757
ICU Medical, Inc. is recalling ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 due to Port weld of drug transfer device may separate or break during use and potentially result in a leak.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Recommended Action
Per FDA guidance
On September 8, 2025, ICU Medical issued an "Urgent Medical Device" Recall notification via E-Mail. ICU Medical ask consignees to take the following actions: 1. Check all inventory locations within your institution for the affected products listed in recall notification and 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 within 10 days of receipt to acknowledge your understanding of this notification. 4. If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to marketaction@mailac.custhelp.com For further inquiries, please contact ICU Medical Customer Service via email: customerservice@icumed.com or call: 1-(800)-258-5361 for additional information or technical assistance. Or contact Field Service Processing via email: marketaction@mailac.custhelp.com for Assistance with Customer Notifications and Response Forms.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026