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Z-1998-2014 Class II Terminated

Recalled by Vascular Technology, Inc. — Nashua, NH

FDA device recall Z-1998-2014 was initiated by Vascular Technology, Inc. on May 28, 2014 and is designated Class II. Reason for recall: Report of the product penetrating the sterile barrier; this could render the product unsterile. The recall status is terminated (terminated February 11, 2016). Affected quantity: 164.

Recall Details

Product Type: Devices
Report Date: July 16, 2014
Initiation Date: May 28, 2014
Termination Date: February 11, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 164

Product Description

07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 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.

Distribution Pattern

Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.

Code Information

LOT NUMBER 11798-37631

Other recalls by Vascular Technology, Inc.

Z-3026-2018 Class II — VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 (June 19, 2018)
Z-2000-2014 Class II — 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe (May 28, 2014)
Z-1999-2014 Class II — 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is (May 28, 2014)
Z-2001-2014 Class II — VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler (May 28, 2014)