Class 1 Device Recall regard

• Date Initiated by Firm: December 26, 2024
• Date Posted: February 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1047-2025
• Recall Event ID: 96094
• Product Classification: Labor and Delivery Kit - Product Code MLS
• Product: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
• Code Information: Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486.
• Recalling Firm/ Manufacturer: ROi CPS LLC; 3000 E Sawyer Rd; Republic MO 65738-2758
• For Additional Information Contact: Lacy Stewart; 417-647-3205
• Manufacturer 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..
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 12/26/2024, the recalling firm issued a notice dated 12/26/2024 via email to their sole consignee notifying them of the recall of the convenience kits. The email also contained the notice issued by the manufacturer of the affected device component. The recalling firm's notice explained the reason for recall, the health risk involved, and the actions to be taken by the consignee, which included: (1) CHECK: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the above table are in your inventory. (2) QUARANTINE: Please quarantine the kits affected by this notice and do not further distribute to end user facilities. (3) NOTIFY: Immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. Provide a copy of this notice to all customers who have received impacted product and require a response. Customer responses will be requested to determine effectiveness of this recall. (4) END USERS: End users are instructed to discontinue use of the affected kits and quarantine. Kits are to be returned to the distribution location. (5) REPLY: Reply to this notice by completing the reply form attached and emailing to lacy.stewart@roiscs.com. (6) CORRECTION: ROi CPS, LLC personnel will conduct correction activities at the distribution location to ensure removal of the recalled Mercury Medical item. The enclosed reply form is for the consignee to report they have read and understand the attached notice. The consignee is to indicate whether they have forwarded the notice to all customers who have been shipped the affected product, whether or not they have the consignee has the affected product, and that they have completed the "Quantity on Hand" portion of the reply form.
• Quantity in Commerce: 414 kits
• Distribution: Distribution was made to MO. There was no government/military/foreign distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.