Recall Z-0673-2013
Vycor Medical, Inc. · initiated August 21, 2012
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Model # TC171105 Lot # VM83450
Reason for recall
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
FDA-determined cause: Equipment maintenance
Action taken
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.
Details
- Recall number
- Z-0673-2013
- Initiated
- August 21, 2012
- Posted by FDA
- January 17, 2013
- Terminated
- May 13, 2013
- Product code
- GZT – Retractor, Self-Retaining, For Neurosurgery
- Quantity
- 3000 devices
- Distribution
- Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
- Recalling firm
- Vycor Medical, Inc., Boca Raton, FL