FDA Recall Terminated

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Recall: Z-3026-2018 · Initiated June 19, 2018

Recall

Recall Number
Z-3026-2018
Event Number
80527
Firm
Vascular Technology, Inc.
FEI Number
1221072
Product Code
DPW
Status
Terminated
Root Cause
Labeling Change Control
Initiated
June 19, 2018
Terminated
January 30, 2020
Address
12 Murphy Drive, Nashua, NH, 03062-1903

Description

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Reason

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

Action

The firm, Vascular Technology, Inc., "URGENT: MEDICAL RECALL DEVICE" letter dated June 18, 2018, to its customer on June 19, 2018. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine inventory and return all product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. If you have any questions, contact VP Sales person at 603-594-9700.

Distribution

US Distribution to state of: CA.

Quantity

10 units