CLASS II Device recall · Reported 18 May 2022 · FDA Enforcement Report

Regard CABG Pack A and B - Spartanburg recalled by ROi CPS

ROi CPS is recalling Regard CABG Pack A and B - Spartanburg, distributed in North Carolina. The recall was initiated on 21 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156

Quantity recalled85 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-1051-2022
FDA event ID: 89951
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2022
FDA classified: 9 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Mar 2022	Recall initiated by company
9 May 2022	Classified by FDA	+49 days
18 May 2022	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

Kits were packed into shipping boxes incorrectly.

Product as listed by the FDA

Regard brand CABG Pack A and B - Spartanburg

Where it was distributed

Recall impacted one domestic consignee in NC

North Carolina

Questions about this recall

Why was it recalled?

Kits were packed into shipping boxes incorrectly.

Which lots are affected?

Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156

Where was it sold?

Recall impacted one domestic consignee in NC

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.

More recalls from ROi CPS

All 86

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS I	regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled	ROi CPS	Potency & Assay	MO
25 Sep 2024Device	CLASS II	regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled	ROi CPS	Packaging Defects	Nationwide
28 Aug 2024Device	CLASS II	Regard Kit containing the Microtek decanter recalled by ROi CPS	ROi CPS	Sterility	Nationwide
24 Jan 2024Device	CLASS I	regard Operative LAP recalled by ROi CPS	ROi CPS	Other	LA
10 Jan 2024Device	CLASS I	Regard Dressing change kit recalled by ROi CPS	ROi CPS	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide