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# ROi CPS Recalls Newborn Kits
- URL: https://www.fdaweb.com/roi-cps-recalls-newborn-kits/
- Published: 2025-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:54:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158746

ROi CPS is recalling (Class 1) its newborn kits after receiving an [Urgent Field Safety Notice for a kit component](https://www.fda.gov/medical-devices/medical-device-recalls/gas-powered-emergency-resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitator-due?ref=fdaweb.com) from supplier Mercury Medical. The component is Mercury’s Neo-Tee T-Piece resuscitator, which is being removed due to an undersized spring in the controller that may prevent the device from delivering the required pressure levels needed for proper ventilation, a recall notice says. “The issue could reduce positive pressure, affecting the patient's breathing support,” it says. To date, there have been no reported injuries or deaths associated with the issue.

The convenience kit contains finished medical devices intended 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,” the notice says.