ROi CPS LLC Recalls
5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (5)
- Class I
December 26, 2024
regard 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..
- Class II
July 24, 2024
regard 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.
- Class II
June 17, 2024
Regard Kit containing the Microtek decanter
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
- Class I
December 18, 2023
regard Operative LAP, Item Number 800943001; surgical convenience kit
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- Class I
November 20, 2023
Regard Dressing change kit, Item Number 800026006
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.