With regard to certain products, manufacturing operations at Atrium’s facilities in Hudson, New Hampshire will be temporarily suspended while corrections are being made. These products will become temporarily unavailable once existing inventory located at our distribution facilities has been exhausted.
For more details, please see the list of Restricted Products below
Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.
For more details, please see the list of Restricted Products Available with Certificate of Medical Necessity below
Operations at three Maquet locations that also fall under the decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally.
All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.
Under the terms of the Decree, manufacturing of these products was discontinued at Atrium's Hudson, New Hampshire facility.
In the time following the release of the consent decree, manufacturing of all Biosurgery products has been restarted at Maquet's new facility in Merrimack, New Hampshire.
Production of the vascular graft product lines is expected to resume at the new Merrimack facility in the thrid quarter of 2015. Some code numbers and sizes will become temporarily unavailable until production is resumed. We regret the inconvenience caused by the temporary unavailability of these products. We are committed to helping you serve your patients, and our sales representatives wil work with you to identify other products that can provide the same or similar service until the products listed below are once again available.
Restricted products include:
|Product Area||Product Name|
|Prolite Self-Forming Plug|
|Prolite Ultra Self-Forming Plug|
|FLIXENE with IFG|
|Advanta SST Large Diameter|
|Vascular Graft Accessories||Tunneler|
|Vein Graft Tunnleing System|
|Vascular Patch||Ivena Vascular Patch|
Restricted Products Available with Certificate of Medical Necessity
Certain products manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S, provided that the authorized representatives of U.S. and International customers have signed the attached CMN form certifying that, after learning from this Notification Guide of the FDA findings at the Atrium Hudson manufacturing facility, and evaluating the relevant risks and benefits, there is an immediate medical need for the continued use and purchase of these products.
Restricted products available with a Certificate of Medical Necessity include:
|Product Area||Product Name||Accessories|
|Oasis Dry Suction Water Seal Drains, including accessories||Oasis Chest Drains||Pneumostat
PVC Firm Catheters
ATS Blood Bags
|Ocean Wet Suction Water Seal Drains, including accessories||Ocean Chest Drains|
|Express Dry Suction dry Seal Drains, including accessories||Express Chest Drains|
|Express Mini-500 Chest Drains|
|Local Therapeutic Infusion Catheters||ClearWay RX Catheter|
|ClearWay OTW Catheter|
|Covered Stents||iCAST Covered Stent (US)|
|Advanta V12 Covered Stent (OUS)|