CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report

Civco Tracking Bracket Starter Kit recalled

Civco Medical Instruments Co is recalling Civco Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with, distributed nationwide in the US. The recall was initiated on 21 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesM093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150

Quantity recalled206 boxes

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-0289-2016
FDA event ID: 72378
Recalling firm: Civco Medical Instruments Co, Kalona, IA
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2015
FDA classified: 17 Nov 2015
Reported: 25 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Oct 2015	Recall initiated by company
17 Nov 2015	Classified by FDA	+27 days
25 Nov 2015	Published in enforcement report	+8 days

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

Reason for recall

Sterility of the product cannot be assured.

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

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

Nationwide Puerto Rico

Questions about this recall

Is Civco Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with recalled?

Yes. Civco Medical Instruments Co recalled Civco Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with on 21 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0289-2016.

Why was it recalled?

Sterility of the product cannot be assured.

Which lots are affected?

M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150

Where was it sold?

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.

More recalls from Civco Medical Instruments Co

All 36

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor - (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide