Z-0673-2013 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2013
- Initiation Date
- August 21, 2012
- Termination Date
- May 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 devices
Product Description
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Reason for Recall
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Distribution Pattern
Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
Code Information
Model # TC171105 Lot # VM83450