Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: Regard Newborn Kit
- Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006
- Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486
What to Do
- Stop use and distribution of affected product.
- Provide a copy of this recall notice to all customers who may have received impacted product.
- Notify anyone who may use these devices.
On December 26, 2024, ROi, CPS LLC sent all affected customers an Urgent Medical Device Correction Notice recommending the following actions:
Actions for customers
- Review inventory to determine if the item and lot numbers are present.
- Quarantine affected kits.
- Do not distribute affected kits to user facilities.
- Notify any customers who may have received affected product.
- Provide a copy of the notice to all customers who have received impacted product and require a response.
- Customer responses will be requested to determine effectiveness of this recall.
Actions for end users
- Do not use affected kits.
- Return kits to the distribution location.
- Reply to the notice by completing the reply form attached to the letter.
- ROi CPS, LLC will make sure all of the impacted Mecury Medical items are removed from the distribution location.
- Report any adverse health consequences experienced to the FDA's MedWatch Adverse Event Reporting program.
Reason for Recall
ROi CPS, LLC, is recalling newborn kits after receiving an Urgent Field Safety Notice for a kit component from the supplier Mercury Medical. The affected component is the Neo-Tee T-Piece resuscitator, which is being removed by Mercury Medical due to a undersized spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. The issue could reduce positive pressure, affecting the patient's breathing support.
The use of affected product may cause serious adverse health consequences, including low oxygen levels (desaturation), slow heart rate (bradycardia), lack of oxygen (hypoxia), high carbon dioxide levels (hypercarbia), and death.
There have been no reported injuries or deaths associated with this issue.
Device Use
The ROi Regard Newborn Kit is a convenience kit containing finished medical devices to be used in Labor and Delivery. The Neo-Tee T-Piece Resuscitator included in the kit is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a facemask or a tube inserted into a patient's airway. It is intended for use with pediatric patients weighing less than 10kg (22lbs). The device is designed with in-line flow controller, in the circuit.
Contact Information
Customers in the U.S. with questions about this recall should contact ROi CS, LLC.
Additional FDA Resources
- Related FDA recall classification summaries
- FDA’s Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.