Device recall: Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

Class II FDA enforcement event 88210. Recall start date: 14 Jun 2021. Status in the FDA record: Terminated. Termination date: 8 Mar 2023.

Reason for recall, in the words of FDA

Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

Class II, in the words of FDA

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

ROi CPS LLC started this device recall on 14 Jun 2021. The firm address in the FDA record is in Republic, MO. FDA put the recall in Class II. FDA event 88210 has 3 product records. The first FDA enforcement report date is 11 Aug 2021. The record gives the status Terminated, with the termination date 8 Mar 2023.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Missouri

Recalling firm

ROi CPS LLC, Republic, MO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 88210: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2167-2021	Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.	608 units	Class II	Terminated	11 Aug 2021
Z-2168-2021	Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.	688 units	Class II	Terminated	11 Aug 2021
Z-2169-2021	Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.	976 units	Class II	Terminated	11 Aug 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 28

Other events of the firm

Other FDA enforcement events of 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

ROi CPS LLC: all 28 events

Official channels

FDA enforcement report Z-2167-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 88210. https://recallregister.com/fda/ii/88210/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Missouri
What quantity of product is in FDA event 88210?: The event has 3 product records. The first record gives this quantity: 608 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.