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U.S. Department of Health and Human Services

Class 2 Device Recall CChemoLock" Port, Bulk, NonSterile

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 Class 2 Device Recall CChemoLock" Port, Bulk, NonSterilesee related information
Date Initiated by FirmSeptember 08, 2025
Date PostedOctober 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0330-2026
Recall Event ID 97583
510(K)NumberK131549 
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
ProductICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Code Information UDI:00887709094505/Lot: 14407400
FEI Number 2025816
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information ContactICU Customer Service
1800-258-5361
Manufacturer Reason
for Recall		Port weld of drug transfer device may separate or break during use and potentially result in a leak.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce2000 units
DistributionWorldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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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