Class 2 Device Recall Regard

• Date Initiated by Firm: May 04, 2020
• Create Date: June 15, 2020
• Recall Status: Terminated on September 23, 2022
• Recall Number: Z-2369-2020
• Recall Event ID: 85632
• Product Classification: Central venous catheter dressing change kit - Product Code PEZ
• Product: Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
• Code Information: Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.
• Recalling Firm/ Manufacturer: Resource Optimization & Innovation LLC; 645 Maryville Centre Dr Ste 200; Saint Louis MO 63141-5846
• For Additional Information Contact: 417-730-3937
• Manufacturer Reason for Recall: There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm's supplier mailed an Urgent: Field Action Notification dated 04/21/2020 The notification informs the customers to remove the affected product from inventory and place it in quarantine immediately. The notification included a label template for printing the appropriate warning label. The customers will affix the warning label on all affected kits affected by the notification in inventory. The label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Labels can be printed. The customers should send quantity and end¿ user information request to the contact listed. The kits do NOT need to be returned and may be used. The letter states, an alternate saline flush solution should be used to accompany patient procedures until field action inventory is depleted. The notification states, if any of the affected products identified above were further distributed, to ensure all end-users are appropriately notified of the product recall. Recall Response Forms should be completed and returned as soon as possible even if customers have no current product inventory.
• Quantity in Commerce: 12,640 units
• Distribution: US Nationwide distribution including in the states of MO, NC.
• 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.