CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report

Regard CV PK recalled by ROi CPS

ROi CPS is recalling Regard CV PK, distributed in Missouri. The recall was initiated on 21 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Quantity recalled134 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-0315-2024
FDA event ID: 93204
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Ongoing
Recall initiated: 21 Sep 2023
FDA classified: 16 Nov 2023
Reported: 22 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Sep 2023	Recall initiated by company
16 Nov 2023	Classified by FDA	+56 days
22 Nov 2023	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

Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

Product as listed by the FDA

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Where it was distributed

Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Where was it sold?

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

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7 Oct 2026Device	CLASS II	System (RED 62 Reperfusion Catheter) recalled by Penumbra	Penumbra	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide