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FDASeptember 8, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

UPCs

10887709098388

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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