Recall Z-2001-2014— Vascular Technology, Inc.

Name: FDA recall Z-2001-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-28

Class II · Terminated

Class II FDA medical device recall by Vascular Technology, Inc., initiated 2014-05-28, terminated 2016-02-11. It names one FDA 510(k) clearance: K082870. Product: VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.. Reason: Report of the product penetrating the sterile barrier; this could render the product unsterile..

Recalling firm: Vascular Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Terminated: 2016-02-11
Firm location: Nashua, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K082870 — VTI INTRAOPERATIVE DOPPLER SYSTEMSVascular Technology Incorporated·cleared 2008-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

Reason for recall

Report of the product penetrating the sterile barrier; this could render the product unsterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.