Class 2 Device Recall regard C Section Kits

• Date Initiated by Firm: March 18, 2022
• Date Posted: April 26, 2022
• Recall Status: Completed
• Recall Number: Z-1004-2022
• Recall Event ID: 89875
• Product Classification: Cesarean section tray - Product Code OHM
• Product: Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
• Code Information: (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.
• Recalling Firm/ Manufacturer: ROi CPS LLC; 3000 E Sawyer Rd; Republic MO 65738-2758
• For Additional Information Contact: Cheyenne L. Stewart; 417-647-3264
• Manufacturer Reason for Recall: A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm sent an email to the consignee on 3/18/2022 which said they have attached an Urgent Device Correction Notice for ROi CPS, LLC Convenience Kits that contain Regard branded IV Start Kits that were manufactured using PDI Prevantics products which were recalled by PDI. Attached to the email were the Urgent Device Correction notice dated 3/18/2022, a label template to be used to label the Regard IV start kits contained in the convenience kits, the original recall letter issued by PDI for their Prevantics products that were recalled, and a reply form. The Urgent Device Correction Notice dated 3/18/2022 explained the reason for the recall and listed the affected kit names and identification. The consignee was to review the inventory to determine if the affected kits were in inventory and to segregate and quarantine the kits noting that only the IV Start kit component within the kit was affected and all other items could be used. The customer was to use the attached label template to print warning labels to be affixed to the Regard IV Start Kits contained within the convenience kits. The label was to be applied to each IV Start Kit in a prominently visible location to end users of the kits and the location of the label should not cover any other critical product information found on the existing product label. The labels said 'URGENT PDI PREVANTICS DRUG RECALL DO NOT USE PREVANTICS SWABSTICK OR MAXI SWABSTICK IN THIS KIT PER THE PDI DRUG RECALL NOTICE DATED 2-4-2022 FORWARDED TO YOUR FACILITY." The consignee was to immediately notify any customers to whom the product was distributed or forwarded and the recall notification from the recalling firm, the notice from PDI, and the label template could be forwarded, as well. A reply form was enclosed for completion to indicate response to the notice. The customer was to respond regarding the number of kits in inventory and that they have read and understood the attached notice, forwarded t
• Quantity in Commerce: 290 convenience 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.