BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Vycor Medical Inc. Recalls Brain Access System Over Potential Contamination


1/31/2013 8:58:19 AM

January 31, 2013 -- Recall Class: Class I

Date Recall Initiated: August 21, 2012

Product: Vycor Viewsite Brain Access System (VBAS), Model #TC171105, Lot #VM83450

This product was manufactured on May 29, 2011 and distributed from June 8, 2012 through July 9, 2012.

Use: The Vycor Medical Viewsite Brain Access System serves as a self-retaining retractor system for brain tissue and provides access to allow the surgeon to see the surgical site during brain and spinal procedures.

Recalling Firm:

Vycor Medical, Inc.

6401 Congress Ave, Suite 140

Boca Raton, Florida 33487-2841

Manufacturer:

Lacey Manufacturing Company

1146 Barnum Ave.

Bridgeport, Connecticut 06610-2705

Reason for Recall: Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product may cause serious adverse health consequences, including death.

Public Contact: Customers with questions can contact the company at 561-558-2020.

FDA District: Florida District Office

FDA Comments: Vycor Medical called their customers requesting that they place products of Model # TC171105, Lot # VM83450 into quarantine until further notice. Vycor Medical asked customers holding the affected lot numbers to call the company immediately. Customers in immediate need of the product should advise the Vycor customer service team who can assist in providing an alternative product.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES