CLASS II Device recall · Reported 30 Sep 2015 · FDA Enforcement Report

Regard Custom Surgical Pack recalled by Resource Optimization &

Resource Optimization & Innovation is recalling Regard Custom Surgical Pack, distributed in Louisiana, South Carolina. The recall was initiated on 19 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes023735

Quantity recalled24 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-2798-2015
FDA event ID: 72008
Recalling firm: Resource Optimization & Innovation, Springfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2015
FDA classified: 21 Sep 2015
Reported: 30 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

19 Aug 2015	Recall initiated by company
21 Sep 2015	Classified by FDA	+33 days
30 Sep 2015	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

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

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 Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.

Where it was distributed

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

Louisiana South Carolina

Questions about this recall

Is Regard Custom Surgical Pack recalled?

Yes. Resource Optimization & Innovation recalled Regard Custom Surgical Pack on 19 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2798-2015.

Why was it recalled?

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Which lots are affected?

023735

Where was it sold?

Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.

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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