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:2/8/2016)... ... February 08, 2016 , ... Steve Helwig & Associates ... vital new community enrichment program, has teamed up with Citizens Opposed to Domestic Abuse ... from intimate abuse. To support all those victimized by the fear of violence in ...
(Date:2/8/2016)... , ... February 08, 2016 , ... Delta Dental of ... help combat pancreatic cancer. , Gary D. Radine, who recently retired as president and ... American Cancer Society’s 2015 CEO of the Year , helped lead the effort ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... While a significant number of women and men with eating disorders report a ... that best predicts the development of an eating disorder. , At the ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... than 50% lower incidence rate of type 2 diabetes in the GrassrootsHealth cohort ... is time to make a change in public health,” states Carole Baggerly, Director ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... speaking on how healthcare companies can use newly released government data on populations ... a population and intervene and capture the value they create to succeed in ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... EAST NORRITON, Pa. , Feb. 8, 2016 ... acquisition of November Research Group (NRG),s pharmacovigilance ... of pharmacovigilance system-related consulting services and an Oracle ... regulatory compliance services to Life Sciences companies. ... acquisition strengthens and expands HighPoint,s life sciences capabilities ...
(Date:2/8/2016)... Pa. , Feb. 8, 2016  As part of ... has announced today the appointment of Lori Chmura ... than 20 years in the industry, Chmura,s extensive experience in ... the advancement of Dune Medical Devices. ... will be responsible for leading all sales, marketing and operational ...
(Date:2/8/2016)... Velano Vascular, a medical technology company transforming ... their practitioners, announced today that the company has raised ... the proceeds from this financing, an extension of a ... to support the development and commercialization of the company,s ... Philadelphia , and a number ...
Breaking Medicine Technology: