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 bro
'/>"/>

SOURCE Atrium Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:4/18/2015)... April 18, 2015 On April 14th, 2015, ... Report , which they say, “exposes a tactical shift by ... malware variants were introduced in 2014 - almost a million ... Day threats to be identified and patched by prominent manufacturers ... clear that doing business in a digital world can be ...
(Date:4/17/2015)... April 18, 2015 Heritage Woods of ... its Supportive Living Week Celebration on April 20 with ... a healthy mind, body and soul. , The community, ... Illinois, serves older adults of all incomes, including those ... independence. , Supportive Living Week is observed every April ...
(Date:4/17/2015)... 2015 Alcohol and Violence , The ... that drinking and driving has been the focus of ... time, the link between alcohol and crime received less ... violence and sexual assault, and their relationship to alcohol ... 5.3 million adults in America were drinking alcohol at ...
(Date:4/17/2015)... (PRWEB) April 17, 2015 Consumers who ... protection without modifications can now use the Insurance Pros ... life insurance policy rates that are featured by leading ... standard plans that are offered are mixed between three ... 18 to 79. There are now term, universal and ...
(Date:4/17/2015)... Most dental patients are not aware that nearly ... by foreign dental laboratories, according to the U.S. International ... than 40 states by their respective state boards of ... has created the “What’s In Your Mouth?” ... consequences that could be associated with using poorly-made dental ...
Breaking Medicine News(10 mins):Health News:Cyber Attackers Continue to Fine Tune Deception and Stealth Tactics According to New Report 2Health News:Cyber Attackers Continue to Fine Tune Deception and Stealth Tactics According to New Report 3Health News:Cyber Attackers Continue to Fine Tune Deception and Stealth Tactics According to New Report 4Health News:Cyber Attackers Continue to Fine Tune Deception and Stealth Tactics According to New Report 5Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 2Health News:Heritage Woods of McLeansboro Affordable Assisted Living to Celebrate Supportive Living Week 3Health News:Narconon Arrowhead Raises Awareness on Alcohol Related Prevention 2Health News:Narconon Arrowhead Raises Awareness on Alcohol Related Prevention 3Health News:General Life Insurance Policy Rates Added to Quotation System at Insurance Website Online 2Health News:National Association Urges Transparency in Dental Industry 2
... Sept. 20 Synova Healthcare Group,Inc. (OTC Bulletin Board: ... $3.3 million in aggregate notional principal amount of its,6.5% ... 2012,and related common stock purchase warrants. This sale was ... of notes and warrants in the,aggregate notional principal amount ...
... drug that is used to improve the survival of ... cerebral palsy in those children, according to results from ... Health and led by Ronald Wapner, M.D., professor of ... obstetrician and gynecologist at NewYork-Presbyterian Hospital/Columbia. , Results of ...
... undergo male to female sex-change surgery are happy with the ... a study of over 200 patients in the September issue ... team from the Departments of Urology and Psychiatry at University ... of 222 patients who had undergone surgery and 70 who ...
... secondhand smoke at home are at increased risk of ... the Journal of Adolescent Health. , Our retrospective study ... with academic test performance, said lead author Bradley Collins, ... the Health Behavior Research Clinic at Temple University. , ...
... children and pets,receive regular check-ups. Equally important for ... Not convinced? That cough could be coming from,contaminated ... your carpet be causing,your sinus headache? Wonder about ... (Photo: http://www.newscom.com/cgi-bin/prnh/20070920/NYFNSA01 ) Service Experts, ...
... N.J., Sept. 19, 2007 -- A single dose ... receptor antagonist, resulted in favorable changes in hemodynamics ... in patients with advanced heart failure (ADHF) who ... ToLvaptan on HemodynamIc Parameters in Subjects with HEart ...
Cached Medicine News:Health News:Synova Completes Sale of $3.3 Million in Senior Convertible Notes and Warrants 2Health News:Synova Completes Sale of $3.3 Million in Senior Convertible Notes and Warrants 3Health News:Repeat steroids to premature infants linked to cerebral palsy 2Health News:Most patients who have male-to-female sex-change surgery are happy, despite complications 2Health News:Secondhand smoke increases teen test failure 2Health News:Would Your Home Receive a Passing Grade in Health Care Check-Up? 2Health News:ECLIPSE data on effects of Otsuka's investigational novel treatment, Tolvaptan 2
(Date:4/16/2015)... China , April 16, 2015 ... leading developer, manufacturer, and marketer of medical devices ... the Securities and Exchange Commission an Annual Report on ... the year ended December 31, 2014. An electronic version ... available on Mindray,s investor relations website at  http://ir.mindray.com ...
(Date:4/16/2015)... OAKS, Calif. , April 16, 2015  Amgen ... report its first quarter financial results on Tuesday, April ... markets. The announcement will be followed by a conference ... Participating in the call from Amgen will be ... and other members of Amgen,s senior management team. ...
(Date:4/16/2015)... 16, 2015  Rosewind Corporation (OTCMKTS: RSWN) announced ... with a newly formed specialty healthcare company focused ... addressing urological disorders. The merged company, which is ... commenced operations and incorporates the pipeline assets of ... strategy is to build a late-stage and commercial ...
Breaking Medicine Technology:Mindray Files Annual Report on Form 20-F with the U.S. Securities and Exchange Commission 2Amgen Announces Webcast Of 2015 First Quarter Financial Results 2Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 2Rosewind Corporation Shifts Focus to Develop Late-Stage Therapeutics for Urological and Related Conditions 3
... Chicago-Area Community Hospital to Offer New Clinical Study to Breast ... ... 29 Little Company of Mary,Hospital and Health Care Centers in ... a new clinical study by Xoft using electronic brachytherapy for the,treatment ...
... Data Posted Online Shows Improvements Across Care Center,Network, ... Fibrosis,Foundation reported today that key indicators of health ... and nutritional status -- are,rising nationwide across its ... outlook for people with CF continues to improve ...
Cached Medicine Technology:Breast Cancer Treatment Is Reduced to One Week 2Cystic Fibrosis Foundation Reports Upward Trend for Key Health Outcomes 2
Controls humeral segments through soft tissue compression while allowing for full range of elbow motion...
... The RCAI Plantar Fasciitis Night Splint ... fasciitis and Achilles tendonitis. It is economical ... adjustable dorsiflexion assist straps for controlled dorsiflexion, ... plantar fascia and Achilles tendon. This feature ...
Comfortably positions the affected foot at 90 to provide continuous and effective stretching of the plantar fascia and Achilles Tendon...
... Bird and Cronin, ... manufacturer of Patient Footwear, ... Patient Care Products. Our ... highest quality and available ...
Medicine Products: