CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report

Vti Bayonet Doppler, 20MHz Doppler Probe, Slim, BX recalled

Vascular Technology is recalling Vti Bayonet Doppler, 20MHz Doppler Probe, Slim, BX 4, distributed in California. The recall was initiated on 28 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT NUMBER 11786-37683

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2001-2014
FDA event ID: 68512
Recalling firm: Vascular Technology, Nashua, NH
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2014
FDA classified: 7 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

28 May 2014	Recall initiated by company
7 Jul 2014	Classified by FDA	+40 days
16 Jul 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

California

Questions about this recall

Why was it recalled?

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

Which lots are affected?

LOT NUMBER 11786-37683

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 68512

This product is part of a recall event; the main page for the event is 07-150-07 Mizuho, Mal Disp Doppler Probe Bx recalled.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2014	CLASS II	07-150-07 Mizuho, Mal Disp Doppler Probe Bx recalled	Vascular Technology	Sterility	CA
16 Jul 2014	CLASS II	07-150-10 Mizuho, Doppler Probe, Slim, Bx recalled	Vascular Technology	Sterility	CA
16 Jul 2014	CLASS II	07-150-12 Mizuho, Mini, Slim, Sterile, Box recalled	Vascular Technology	Sterility	CA

More recalls from Vascular Technology

All 5

Reported	Class	Recall	Company	Reason	Where
19 Sep 2018Device	CLASS II	VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel recalled	Vascular Technology	Labeling Errors	CA
16 Jul 2014Device	CLASS II	07-150-12 Mizuho, Mini, Slim, Sterile, Box recalled	Vascular Technology	Sterility	CA
16 Jul 2014Device	CLASS II	07-150-10 Mizuho, Doppler Probe, Slim, Bx recalled	Vascular Technology	Sterility	CA
16 Jul 2014Device	CLASS II	07-150-07 Mizuho, Mal Disp Doppler Probe Bx recalled	Vascular Technology	Sterility	CA

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