The Food and Drug Administration has temporarily suspended all US shipments of QUADROX oxygenators and holding clamps. The FDA has recently reviewed the documentation supporting the use of the holding clamp used in conjuction with the QUADROX oxygenators. Upon review, FDA has requested that this information be formally submitted to FDA for clearance. Maquet is currently compiling the submission and is discussing with FDA how quickly the hold can be lifted.
If you currently have a stocking agreement or utilize MAQUET custom tubing packs, we kindly request that you contact your local MAQUET Perfusion Territory Manager to discuss pack modification to remove your oxygenator.