ROi CPS LLC: Device Recall

Recall #Z-2685-2024 · 06/17/2024

Class II: Risk

Recall Details

Recall Number: Z-2685-2024
Classification: Class II
Product Type: Device
Recalling Firm: ROi CPS LLC
Status: Ongoing
Date Initiated: 06/17/2024
Location: Republic, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 78 Kits

Reason for Recall

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

Product Description

Regard Kit containing the Microtek decanter

Distribution Pattern

US Nationwide distribution in the state of MO.

Other Recalls by ROi CPS LLC

Class I: Dangerous 12/26/2024

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

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

View all recalls by ROi CPS LLC →

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.