Class 2 Device Recall Regard custom cardiovascular procedural pack

• Date Initiated by Firm: March 04, 2021
• Create Date: April 08, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1376-2021
• Recall Event ID: 87472
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Regard, Item Number 830067009, custom cardiovascular procedure kit
• Code Information: Lot number: 75818I; Expiration Date: 05/18/2021
• FEI Number: 3014527682
• 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: ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
• FDA Determined Cause: Process control
• Action: A Recall notification letter titled, "URGENT - MEDICAL DEVICE RECALL NOTICE" and the Ecolab-Microtek recall notification were sent to the one consignee on 03/04/2021 via email. The recalling firm requested that the consignee review their inventory and immediately quarantine the affected Regard custom procedure kit lot if identified. The consignee is to complete the attached reply form indicating inventory on hand. The notice instructed the consignee to ensure that the notice is issued to the end users whom the kits were further distributed to using their internal recall procedures. The end user is instructed not to use the affected kits containing the recalled Ecolab-Microtek item. The firm provided contact information so that the affected kits can be returned.
• Quantity in Commerce: 16 kits
• Distribution: US Nationwide distribution in the state of Missouri.
• 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.