Recall Z-2000-2014— Vascular Technology, Inc.

Name: FDA recall Z-2000-2014
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: 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 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

07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 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.