Class 2 Device Recall Turbett Surgical Container

• Date Initiated by Firm: December 05, 2022
• Date Posted: January 30, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1037-2023
• Recall Event ID: 91314
• 510(K)Number: K153025
• Product Classification: Wrap, sterilization - Product Code FRG
• Product: Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
• Code Information: GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers
• Recalling Firm/ Manufacturer: Turbett Surgical, Inc.; 668b Phillips Rd Ofc 1; Victor NY 14564-9741
• For Additional Information Contact: Same; 585-755-0133
• Manufacturer Reason for Recall: Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
• FDA Determined Cause: Device Design
• Action: ***UPDATE*** Turbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. " Missing side supports " Broken or cracked side tab support " Backwall weld separation " Side weld separation " Crack in the backwall seam 2. Email (quality@turbettsurgical.com) with the following information. " Hospital name " Serial number(s) " Type of failure that your container exhibited 3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit. If your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container. 4. If your container does not exhibit any of these failures, please email quality@turbettsurgical.com stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container. If you have any questions about the content of this letter, please contact Mark Petras at quality@turbettsurgical.com. ________________________________________________________________________ Turbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take: 1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.
• Quantity in Commerce: 61 units
• Distribution: US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
• 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.

• 510(K) Database: 510(K)s with Product Code = FRG and Original Applicant = TURBETT SURGICAL LLC