CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report

Civco Sales Demo Kit recalled by CIVCO Medical Instruments Co

CIVCO Medical Instruments Co is recalling Civco Sales Demo Kit. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBoxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Quantity recalled135 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-0576-2019
FDA event ID: 81361
Recalling firm: CIVCO Medical Instruments Co, Coralville, IA
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2018
FDA classified: 7 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Nov 2018	Recall initiated by company
7 Dec 2018	Classified by FDA	+35 days
19 Dec 2018	Published in enforcement report	+12 days

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

Reason for recall

Not stated in the enforcement report.

Product as listed by the FDA

CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.

Where it was distributed

Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Questions about this recall

Why was it recalled?

The reason has not been published.

Which lots are affected?

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

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.

Other products in this recall event

14 other products · FDA event 81361

This product is part of a recall event; the main page for the event is SonoSite Fujifilm Needle Guide Bracket recalled.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018	CLASS II	SonoSite Fujifilm Needle Guide Bracket recalled	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Biopsy Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	SonoSite Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket recalled	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA

More recalls from CIVCO Medical Instruments Co

All 23

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Device	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018Device	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018Device	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018Device	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA
19 Dec 2018Device	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	CIVCO Medical Instruments Co	Sterility	IA

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