ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

ICU notified consignees via email with an "URGENT MEDICAL DEVICE CORRECTION" on about 10/02/2025. Consignees were instructed to: 1) Check all inventory locations within your institution for the affected products 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. ICU Medical will provide replacement products to affected customers upon receipt of a complete Customer Response Form to certify product destruction. If you have any questions, contact Customer Service via email: customerservice@icumed.com or call 1-(800)-258-5361 Additional information or technical assistance.

• FDA enforcement recordOfficial FDA database entry for Z-0154-2026
• FDA 510(k) clearance · K964435The device's official FDA premarket clearance record
• FDA device classification · FMGOfficial 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.