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FDAAugust 1, 2022device

8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;

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

The hazard

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

What to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

UPCs

575548557720875735432578770057899845800993

Recall history

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

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8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer; — Recall Details · AllClear