ROi CPS LLC

3 FDA enforcement actions

3 Total Recalls

1 Class I

2 Class II

0 Class III

Firm Details

Product Types: device
States: MO

All Recalls

Class I: Dangerous 12/26/2024 device

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: Risk 07/24/2024 device

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Class II: Risk 06/17/2024 device

Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.