CLASS II Device recall · Reported 14 Oct 2015 · FDA Enforcement Report

regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk recalled

Resource Optimization & Innovation is recalling regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical, distributed in Louisiana, Mississippi, Texas. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 20112 and 23060.

Quantity recalled510 kits

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-0091-2016
FDA event ID: 71904
Recalling firm: Resource Optimization & Innovation, Springfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 7 Oct 2015
Reported: 14 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

22 Apr 2015	Recall initiated by company
7 Oct 2015	Classified by FDA	+168 days
14 Oct 2015	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 kits contain an equipment glove component which may contain splits or holes compromising the sterility.

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

regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Where it was distributed

Distribution was made to LA, MS, and TX.

Louisiana Mississippi Texas

Questions about this recall

Is regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical recalled?

Yes. Resource Optimization & Innovation recalled regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-0091-2016.

Why was it recalled?

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Which lots are affected?

Lot numbers 20112 and 23060.

Where was it sold?

Distribution was made to LA, MS, and TX.

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 Resource Optimization & Innovation

All 228

Reported	Class	Recall	Company	Reason	Where
27 Apr 2022Device	CLASS II	Regard IV Start Kit for preparing and/or dressing recalled	Resource Optimization & Innovation	Other	MO
5 Aug 2020Device	CLASS II	regard Migrating Indicator, Steam Migrating Indicator Strips recalled	Resource Optimization & Innovation	Sterility	Nationwide
24 Jun 2020Device	CLASS II	Regard SRHS GIC Port A Cath, Sterile, Qty recalled	Resource Optimization & Innovation	Sterility	Nationwide
24 Jun 2020Device	CLASS II	Regard SRHS Central Line Kit, Sterile recalled	Resource Optimization & Innovation	Sterility	Nationwide
29 Nov 2017Device	CLASS II	Regard Custom Surgical Pack Packs contain surgical recalled	Resource Optimization & Innovation	Labeling Errors	TX

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