CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report

Regard, Item Number 830565001, CV0654A - Pediatric Heart - Custom recalled

Resource Optimization & Innovation is recalling Regard, Item Number 830565001, CV0654A - Pediatric Heart - Custom, distributed in Louisiana, Texas. The recall was initiated on 25 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes19532, 27389, 24399, and 24478

Quantity recalled57 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-0188-2016
FDA event ID: 72052
Recalling firm: Resource Optimization & Innovation, Springfield, MO
Classification: Class II
Status: Terminated
Recall initiated: 25 Aug 2015
FDA classified: 29 Oct 2015
Reported: 4 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

25 Aug 2015	Recall initiated by company
29 Oct 2015	Classified by FDA	+65 days
4 Nov 2015	Published in enforcement report	+6 days

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

Reason for recall

Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting 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, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.

Where it was distributed

Distributed in Texas and Louisiana.

Louisiana Texas

Questions about this recall

Why was it recalled?

Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

Which lots are affected?

19532, 27389, 24399, and 24478

Where was it sold?

Distributed in Texas and Louisiana.

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 26 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

7 other products · FDA event 72052

This product is part of a recall event; the main page for the event is Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom recalled.

Reported	Class	Recall	Company	Reason	Where
4 Nov 2015	CLASS II	Regard, Item Number 830054001, CV00625A - Open Heart A&B - Custom recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 830019, CV0214H -Custom surgical kit recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 800301001, Sterile, CV0708A - Open Heart- Custom recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 830045, CV0443D - CV Bundle recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 830500003, Sterile, CV0578C - CV Pack - Custom recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 800500002, Sterile, CV0578B - CV Pack- Custom recalled	Resource Optimization & Innovation	Sterility	LA, TX
4 Nov 2015	CLASS II	Regard, Item Number 830054002, CV00625B - Open Heart A&B - Custom recalled	Resource Optimization & Innovation	Sterility	LA, TX

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	Device Malfunction	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

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