FDAMarch 5, 2015device

Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes ca...

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

The hazard

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascular us salesmaquetmaquet cardiovascular

Recall history

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

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