Class 2 Device Recall Regard Custom Surgical Pack

• Date Initiated by Firm: August 19, 2015
• Date Posted: September 21, 2015
• Recall Status: Terminated on April 05, 2017
• Recall Number: Z-2798-2015
• Recall Event ID: 72008
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
• Code Information: 023735
• FEI Number: 3004513970
• Recalling Firm/ Manufacturer: Resource Optimization & Innovation Llc; 2909 N Neergard Ave; Springfield MO 65803
• For Additional Information Contact: Robert W. Callahan; 314-364-6461
• Manufacturer Reason for Recall: Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
• FDA Determined Cause: Material/Component Contamination
• Action: On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.
• Quantity in Commerce: 24 kits
• Distribution: Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
• 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.