Atrium Medical Corporation and three other affiliated Maquet companies have reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and it establishes a framework that provides assurances to FDA that we will complete the improvements currently underway to strengthen our quality management system.
The Decree we have entered into provides us with a clear path forward to complete the enhancement of our quality management system and to continue to provide products of the highest medical quality.
There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.
We regret the inconvenience caused by the temporary unavailability of some of our products. We are committed to helping you serve your patients, and our sales representatives will work with you to identify other products that can provide the same or a similar service once our products become temporarily unavailable.
Chief Executive Officer
MAQUET Holding B.V. & Co KG