Class 2 Device Recall regard

• Date Initiated by Firm: October 20, 2022
• Date Posted: November 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0303-2023
• Recall Event ID: 91069
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: regard CVPART1BUNDLE- MERCYSTANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
• Code Information: UDI/DI 10194717114895, Lot Numbers: 92534, exp 11/13/2022; 93366, exp 2/28/2023
• 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: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
• FDA Determined Cause: Component change control
• Action: ROi CPS, LLC issued a MEDICAL DEVICE CORRECTION NOTICE on 10/20/2022 by email to its consignees. The notice explained the issue, the distribution dates, and kits specific to each consignee, and requested the following: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the chart above are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits in your inventory. 3. LABEL: Use the attached label template (Ro; CPS Correction INC13225-3M Recall Label Template-Avery 5960) to print warning labels to be affixed to all affected kits in your inventory. The label should be applied to each affected Kit and outer product case in a prominently visible location to end-users of the kits. The location chosen should not cover any other critical product information found on the existing product labeling. The label instructs users to remove and discard the 3M Steri-Drapes when the kit is opened for use. 4. REPLY: Complete the reply form included with this notice to indicate your actions in response to this notice. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. b. Return the reply form to lacy.stewart@roiscs.com 5. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from 3M, and the attached label template with your customer notification. 6. REPORT: Report any adverse health consequences experienced with the 3M products to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-9787"
• Quantity in Commerce: 108 kits
• Distribution: LA, MO, NC, FL
• 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.