NASHVILLE, TN – Medical providers and patients are advised that a number of ROi Regard Newborn Kits have been recalled by ROi CPS, LLC, because the controller of the device’s Neo-Tee T-Piece Resuscitator was found to have an undersized spring.
Announced on the FDA website on Friday, February 28, 2025, the recall was identified as Class I, the most serious type, because the defect puts users at risk for significant injury or even death. ROi CPS, LLC, took action after receiving an Urgent Field Safety Notice regarding a kit component produced by the supplier Mercury Medical.
A convenience kit comprised of “finished medical devices to be used in Labor and Delivery,” the ROi Regard Newborn Kit includes a Neo-Tee T-Piece Resuscitator. Said resuscitator is gas-powered and designed to provide emergency respiratory assistance, which is conveyed through a face mask or by way of a tube placed in a patient’s airway. Built with the in-line flow controller in the circuit, the device is indicated for use by pediatric patients weighing below 10 kg., or 22 lbs.
The controller’s undersized spring is believed to cause the device from ventilating at adequate pressure levels. A patient may not have the breathing support they need without positive pressure.
While the company has not received any reports of injuries or deaths associated with the affected product, users are said to be subject to the following adverse health outcomes:
- low oxygen levels (desaturation)
- slow heart rate (bradycardia)
- lack of oxygen (hypoxia)
- high carbon dioxide levels (hypercarbia)
- death
The following lots of Regard Newborn Kits, along with their respective expiration dates and UDIs (Universal Device Identifiers), are covered by the recall:
- 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
Anyone who may be in possession of a kit in one of the above lots is asked to cease all use and distribution of the devices as well as to forward the recall notice to all potentially impacted customers. Anyone who may be using the devices should be notified.
An Urgent Medical Device Correction Notice sent out by ROI CPS, LLC, on December 26, 2024, outlined a list of recommended actions for customers and end users.
Healthcare providers and consumers alike are encouraged to share any related adverse issues with the FDA’s MedWatch program.
Has your child suffered an adverse health outcome believed to be connected to a device defect? Your family deserves quality and compassionate legal assistance. Our trusted attorneys at Oliver Law Office have a range of experience in mass tort litigation and are prepared to investigate your case. Let us help you fight for justice and the compensation you need to cover associated expenses. Contact our office at 614-220-9100 or online to book a free case evaluation.
