Class 2 Device Recall Vitrectomy Tray

• Date Initiated by Firm: August 10, 2021
• Create Date: November 18, 2021
• Recall Status: Terminated on June 16, 2023
• Recall Number: Z-0256-2022
• Recall Event ID: 88463
• Product Classification: Eye tray - Product Code OJK
• Product: REGARD Vitrectomy Tray
• Code Information: Lots numbers: 89042C and 85120B
• 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: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
• Quantity in Commerce: 22 trays
• Distribution: US Nationwide in the states of FL, LA and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.