ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike REF: CL-10

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0341-2026
• FDA 510(k) clearance · K131549The device's official FDA premarket clearance record
• FDA device classification · ONBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ICU Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.