Class 2 Device Recall CV Part 1 Bundle

• Date Initiated by Firm: June 17, 2024
• Date Posted: August 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2685-2024
• Recall Event ID: 94999
• Product Classification: Container, i.V. - Product Code KPE
• Product: Regard Kit containing the Microtek decanter
• Code Information: Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
• FEI Number: 3014527682
• Recalling Firm/ Manufacturer: ROi CPS LLC; 3000 E Sawyer Rd; Republic MO 65738-2758
• For Additional Information Contact: Lacy Stewart; 417-730-3900
• Manufacturer Reason for Recall: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
• FDA Determined Cause: Pending
• Action: The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.
• Quantity in Commerce: 78 Kits
• Distribution: US Nationwide distribution in the state of MO.
• 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.