Enforcement Report - Week of January 23, 2013
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Product Detail
| 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. |
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| Recall Number | Z-0673-2013 |
| Classification | Class I |
| Code Info | Model # TC171105 Lot # VM83450 |
| Product Distributed Qty | 3000 devices |
| Reason For Recall | Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. |
Event Detail
| Event Id | 63319 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Vycor Medical, Inc. |
| City | Boca Raton |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-21 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | 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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