Recalls / —

—#216211

Product

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

FDA product code

ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K131549

Affected lot / code info

Lot:14407070,14384996,14391949; Distributed in Canada

Why it was recalled

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

ICU Medical, Inc.

Address

951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern

Worldwide 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.

Timeline

Recall initiated

2025-09-08

Posted by FDA

2025-10-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #216211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.