CLASS II Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Nonsterile convenience kits: regard recalled by ROi CPS

ROi CPS is recalling Nonsterile convenience kits: regard, distributed in Missouri. The recall was initiated on 3 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

Quantity recalled86 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-1407-2022
FDA event ID: 90492
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2022
FDA classified: 19 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Other Medical Devices

Timeline

3 Jun 2022	Recall initiated by company
19 Jul 2022	Classified by FDA	+46 days
27 Jul 2022	Published in enforcement report	+8 days

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

Reason for recall

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

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

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

Where it was distributed

Distribution was made to MO. There was no foreign/military/government distribution.

Missouri

Questions about this recall

Is Nonsterile convenience kits: regard recalled?

Yes. ROi CPS recalled Nonsterile convenience kits: regard on 3 Jun 2022. The recall is Class II and its status is Terminated. Recall number Z-1407-2022.

Why was it recalled?

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Which lots are affected?

(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

Where was it sold?

Distribution was made to MO. There was no foreign/military/government distribution.

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 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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