CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report

Civco Needle Guide recalled by Civco Medical Instruments Co

Civco Medical Instruments Co is recalling Civco Needle Guide. The recall was initiated on 30 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 00841436107334, Lot numbers: A035054, A042207

Quantity recalled3 units

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-2947-2018
FDA event ID: 80656
Recalling firm: Civco Medical Instruments Co, Kalona, IA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2018
FDA classified: 29 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Syringes & Needles

Timeline

30 Jul 2018	Recall initiated by company
29 Aug 2018	Classified by FDA	+30 days
5 Sep 2018	Published in enforcement report	+7 days

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

Reason for recall

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

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 Needle Guide, REF 676-150, QTY 24, STERILE EO

Where it was distributed

United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

Stores named: Walmart

Questions about this recall

Is Civco Needle Guide recalled?

Yes. Civco Medical Instruments Co recalled Civco Needle Guide on 30 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2947-2018.

Why was it recalled?

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

Which lots are affected?

UDI 00841436107334, Lot numbers: A035054, A042207

Where was it sold?

United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

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

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