| Date Posted |
January 17, 2013 |
| Recall Number |
Z-0673-2013 |
| Product |
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. |
| Code Information |
Model # TC171105
Lot # VM83450
|
Recalling Firm/
Manufacturer |
Vycor Medical, Inc.
6401 Congress Ave Ste 140
Boca Raton, Florida 33487-2841 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
|
| Action |
Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020. |
| Quantity in Commerce |
3000 devices |
| Distribution |
Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan. |
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