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VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** ...

FDA Recall #Z-1069-2014 — Class II — December 12, 2013

Recall #Z-1069-2014 Date: December 12, 2013 Classification: Class II Status: Terminated

Product Description

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.

Reason for Recall

Sterility of medical devices intended for use in surgical procedures may be compromised.

Recalling Firm

Terumo Cardiovascular Systems Corporation — Elkton, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

26 units

Distribution

USA Nationwide Distribution in the state of LA, NJ, and NY.

Code Information

Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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