FDAOctober 4, 2019device

REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139

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

The hazard

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

What to do

FDA enforcement status: Terminated

Brands named

icu medicalicu

UPCs

00887709088139

Recall history

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

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