Class 2 Device Recall Centurion

• Date Initiated by Firm: September 07, 2022
• Date Posted: October 20, 2022
• Recall Status: Completed
• Recall Number: Z-0106-2023
• Recall Event ID: 90901
• Product Classification: General surgery tray - Product Code LRO
• Product: CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
• Code Information: UDI/DI 20653160222979, Lot Code 2022050690
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 866-359-1704
• Manufacturer Reason for Recall: One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries issued a Medical Device Recall note on 09/08/2022 by mail and email. The notice explained the problem and the potential hazard and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-131-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."
• Quantity in Commerce: 18 kits
• Distribution: US Nationwide distribution in the states of CA and TX.
• 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.