Device recall: Regard, Item Number 830067009, custom cardiovascular procedure kit

FDA enforcement event 87472 · Class II · initiated 4 Mar 2021 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordRepublic, MO

FDA enforcement event 87472 is a device recall by ROi CPS LLC of Republic, MO, initiated 4 Mar 2021 and classified Class II, with 1 product record.

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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Ongoing. 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

"ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment."

Distribution

"US Nationwide distribution in the state of Missouri."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1376-2021	Regard, Item Number 830067009, custom cardiovascular procedure kit	16 kits	Class II	Ongoing	14 Apr 2021

Context

89%of 2021 device events are Class II900 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: "ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment."

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 Nationwide distribution in the state of Missouri."

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.