ROi CPS LLC: Device Recall

Recall #Z-1047-2025 · 12/26/2024

Class I: Dangerous

Recall Details

Recall Number: Z-1047-2025
Classification: Class I
Product Type: Device
Recalling Firm: ROi CPS LLC
Status: Ongoing
Date Initiated: 12/26/2024
Location: Republic, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 414 kits

Reason for Recall

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..

Product Description

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Distribution Pattern

Distribution was made to MO. There was no government/military/foreign distribution.

Other Recalls by ROi CPS LLC

Class II: Risk 07/24/2024

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

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

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.