Navigation Links
Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE(TM) Brand Heparin-Coated Thoracic Drainage Catheters Used for Autotransfusion During Cardiopulmonary Bypass Surgery
Date:5/11/2008

HUDSON, N.H., May 12 /PRNewswire/ -- Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE(TM) Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. The U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS. While Atrium's HYDRAGLIDE Catheters do not contain high levels of heparin, there still exists a potential exposure of OSCS to the patient.

Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. Atrium will be working with our customers to replace the affected product as soon as possible. If a non-elective procedure requires use of this catheter, we recommend that you do not use the catheter with either a cell saver autotransfusion system or direct autotransfusion chest drainage collection system for cardiopulmonary bypass surgery.

Atrium has not received reports of any OSCS-related adverse events arising from any use of their Hydraglide Thoracic Catheters. This voluntary recall is being initiated as a precaution to minimize any future potential risk.

The above Customer Notification actions are being taken with the knowledge of the U.S. Food and Drug Administration. Physicians and hospital personnel with product related questions should call the company at 1-800-5-ATRIUM, Monday-Friday, 8:00 AM to 5:00 PM EST.

About Atrium

Atrium's vast expertise in medical device technologies for the treatment of cardiovascular disease, hernia and adhesion prevention has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, and soft tissue repair. Maintaining a commitment to the latest ISO13485 Quality Standards, state-of-the-art manufacturing and automation, cell biology and biomaterial discovery programs, Atrium continues to excel in those healthcare segments that require more advanced surgical intervention for improvements in patient outcome. For more information, call 800-370-7899 or visit http://www.atriummed.com.


'/>"/>
SOURCE Atrium Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Statehouse Atrium to be Site for Childrens Dental Access Event - Ohio Legislators to Mingle With Children and Dentists for This Free Care Event!
2. QLT initiates phase II study of punctal plug drug delivery system for glaucoma & ocular hypertension
3. Vista Partners Initiates Coverage on Arana Therapeutics (ASX: AAH; AIM: AAHx)
4. MGH initiates phase I diabetes trial
5. Wasserman Morris Initiates Research Coverage on Crdentia
6. Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Acetaminophen
7. Akela Pharma initiates its first abuse deterrent opioid Phase I clinical trial
8. AAP Initiates Public Relations Effort to Counter Bad Vaccine Publicity
9. China Holdings Announces Starwood Research Institute Initiates Research Coverage
10. Edwards Lifesciences Initiates Patent Infringement Litigation Against CoreValve in the U.S.
11. PreMD Initiates FDA Review Process and Provides Corporate Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... ... 2017 , ... Tribble Insurance Agency, a family owned and operated firm offering ... charity event to honor Chad Phillip Dermyer, a local police trooper who was shot ... and his fellow officers were conducting routine stops of suspects when one of them, ...
(Date:1/19/2017)... ... January 19, 2017 , ... For the second consecutive year, ... Connecticut (RMACT) have earned “Top Doctor” awards. Dr. Mark Leondires, Dr. Spencer Richlin, ... been chosen by their peers for the 2017 list based on their exceptional ...
(Date:1/19/2017)... ... January 19, 2017 , ... Sales Focus Inc. (SFI), a Maryland-based sales ... market. , Over the past 20 years SFI has been recognized as the world’s ... six new clients into the US market. The new clients include: Panacea Pro, ...
(Date:1/19/2017)... ... January 19, 2017 , ... Fillers are known ... Few people know that popular cosmetic fillers can enhance earlobes and ... medical director of the MilfordMD Cosmetic Dermatology Surgery & Laser Center, in Milford, ...
(Date:1/18/2017)... ... January 18, 2017 , ... ... of Bioengineering are collaborating on a research project focused on multiple sclerosis (MS). ... seeks to use nanotechnology to control the disease without compromising normal immune function ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , January 19, 2017 ... administration appears serious about reducing the FDA,s regulatory ... innovation in the medical drug industry, many of ... with new clinical trials and development of advanced ... forging ahead with recent developments include:  Moleculin Biotech, ...
(Date:1/19/2017)... 2017  Magnetic Insight Inc., leader in magnetic ... agreement with inviCRO LLC to develop intuitive image ... based on inviCRO,s VivoQuant™ visualization and post processing ... complete MPI solution package with the Momentum MPI ... imaging in vivo. MPI is a ...
(Date:1/18/2017)... 18, 2017  EnteroMedics Inc. (NASDAQ: ... neuroblocking technology to treat obesity, metabolic diseases and ... an underwritten public offering of units for gross ... discounts and commissions and offering expenses payable by ... Class A Units, priced at a public offering ...
Breaking Medicine Technology: