CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report

regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled

ROi CPS is recalling regard Clinical Packaging Solutions, HT00376I - Special Procedure, distributed nationwide in the US. The recall was initiated on 24 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS

Quantity recalled3387 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-3159-2024
FDA event ID: 95229
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jul 2024
FDA classified: 17 Sep 2024
Reported: 25 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Jul 2024	Recall initiated by company
17 Sep 2024	Classified by FDA	+55 days
25 Sep 2024	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

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Where it was distributed

US Nationwide distribution in the state of North Carolina.

Nationwide North Carolina

Questions about this recall

Why was it recalled?

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

Which lots are affected?

GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS

Where was it sold?

US Nationwide distribution in the state of North Carolina.

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

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12 Feb 2025Device	CLASS I	regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled	ROi CPS	Potency & Assay	MO
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
22 Nov 2023Device	CLASS II	Regard CV PK recalled by ROi CPS	ROi CPS	Other	MO

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