Reported Jan 23, 2013 · Terminated
Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain…
Vycor Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vycor Medical, Inc. · 6401 Congress Ave Ste 140 · Boca Raton, FL · 33487-2841
Is this the product you have?
- Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***
- Product UsageThe 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
- Lot codes and dates
- Model # TC171105 Lot # VM83450
- Amount recalled
- 3000 devices
Where it was sold
Why it was recalled
Stop using this product now
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Using this product could cause serious injury, illness or death — stop using it now.
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