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FDAMarch 5, 2020device

GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

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

The hazard

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

What to do

FDA enforcement status: Terminated

Brands named

baxter healthcarebaxter

UPCs

511100250060

Recall history

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

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