Recall Z-0338-2026— ICU Medical, Inc.

Name: FDA recall Z-0338-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-08

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-09-08. It names one FDA 510(k) clearance: K131549. Product: ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151. Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-08
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131549 — CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc.·cleared 2013-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.