FDAClass IIMarch 5, 2014

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System recall: Sterility Concern

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel…

Why was VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel…
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
26 units
Distribution
USA Nationwide Distribution in the state of LA, NJ, and NY.
Recall date
March 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls