FDAClass IISeptember 19, 2018

VTI 8 MHz Surgical Doppler Transceiver Selectabable recall: Labeling Error

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative…

Why was VTI 8 MHz Surgical Doppler Transceiver Selectabable recalled?

Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

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?

Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.

Product
VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative…
Recalling firm
Vascular Technology, Inc.
Quantity
10 units
Distribution
US Distribution to state of: CA.
Recall date
September 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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