ROi CPS LLC: Device Recall

Recall #Z-3159-2024 · 07/24/2024

Class II: Risk

Recall Details

Recall Number: Z-3159-2024
Classification: Class II
Product Type: Device
Recalling Firm: ROi CPS LLC
Status: Ongoing
Date Initiated: 07/24/2024
Location: Republic, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3387 kits

Reason for Recall

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

Product Description

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Distribution Pattern

US Nationwide distribution in the state of North Carolina.

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 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.