Class 2 Device Recall Regard

• Date Initiated by Firm: April 20, 2020
• Create Date: June 05, 2020
• Recall Status: Terminated on August 21, 2020
• Recall Number: Z-2265-2020
• Recall Event ID: 85591
• Product Classification: Plastic surgery and accessories kit - Product Code FTN
• Product: Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
• Code Information: Lot no. 68336DRW. Item number: 830034. UDI: (01) 10326053106634 (17) 210131 (10) 68336DRW.
• Recalling Firm/ Manufacturer: ROi CPS LLC; 3000 E Sawyer Rd; Republic MO 65738-2758
• For Additional Information Contact: 417-730-3900
• Manufacturer Reason for Recall: Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.
• FDA Determined Cause: Other
• Action: ROi CPS, LLC notified customer on 04/23/2020 via "Urgent Medical Device Recall Notice" The recall letter identified the affected product requested the users to review their inventory and quarantine the affected lots. The consignees were asked to complete and return the recall form.
• Quantity in Commerce: 40 Kits.
• Distribution: US nationwide distribution in the states of MO, AR and OK.
• 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.