ROi CPS LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ROi CPS LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-12FDA-DeviceClass Iregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
- 2024-09-25FDA-DeviceClass IIregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
- 2024-08-28FDA-DeviceClass IIRegard Kit containing the Microtek decanter
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
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