Device recall: Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82

FDA enforcement event 86830 · Class II · initiated 9 Nov 2020 · status Terminated · terminated 13 May 2021

DeviceVoluntary: Firm initiated1 product recordRepublic, MO

ROi CPS LLC (Republic, MO) initiated this device recall on 9 Nov 2020; FDA lists 1 product record under event 86830, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 13 May 2021. Initiation: voluntary: firm initiated. ROi CPS LLC has 28 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ROi CPS LLC, Republic, MO.

Reason for recall

"Gauze sponges contained in custom kits may be flaking or fraying."

Distribution

"US Domestic Distribution Only: MO, NC, LA and FL."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0737-2021	Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot #…	17,700 total kits	Class II	Terminated	6 Jan 2021

Context

93%of 2020 device events are Class II916 events that year

1product record in this eventfirm median: 1

28events on this register for the firm

Other enforcement events for ROi CPS LLC

Initiated	Product (first record)	Type	Class	Records
26 Dec 2024	regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to	Device	Class I	1
24 Jul 2024	regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009	Device	Class II	1
17 Jun 2024	Regard Kit containing the Microtek decanter	Device	Class II	1
18 Dec 2023	regard Operative LAP, Item Number 800943001; surgical convenience kit	Device	Class I	1
20 Nov 2023	Regard Dressing change kit, Item Number 800026006	Device	Class I	1
21 Sep 2023	Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit	Device	Class II	1
11 Sep 2023	GS0008 2Y - Burn Pack - STL, Item Number 880082025	Device	Class II	1
22 Mar 2023	Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Numb	Device	Class II	8
20 Oct 2022	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	Device	Class II	40
3 Jun 2022	Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV	Device	Class II	2

All 28 events for ROi CPS LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Gauze sponges contained in custom kits may be flaking or fraying."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Domestic Distribution Only: MO, NC, LA and FL."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.