Class 1 Device Recall Sheridan Endotracheal Tube

• Date Initiated by Firm: June 07, 2019
• Date Posted: July 30, 2019
• Recall Status: Terminated on July 28, 2020
• Recall Number: Z-1956-2019
• Recall Event ID: 83202
• 510(K)Number: K822082 K091761
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Code Information: Lot 2018110290
• Recalling Firm/ Manufacturer: Centurion Medical Products Corporation; 100 Centurion Way; Williamston MI 48895-9086
• Manufacturer Reason for Recall: Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
• FDA Determined Cause: Device Design
• Action: On June 7, 2019, Centurion notified Medline (the distributor) that they were conducting a recall via an Urgent Product Recall Notice. Medline was instructed to cease further distribution and to notify any customers who received this product. On June 14, 2019, Medline informed its customer of the recall via a letter titled "CENTURION MEDICAL PRODUCT SUB-RECALL*** IMMEDIATE ACTION REQUIRED". REQUIRED ACTION FOR CUSTOMERS: 1. Immediately check your stock for the affected item number and the affected lot number listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. ***Updated 8/2/19*** In July 2019, due to an amendment to the letter from Teleflex, the supplier, Centurion sent a revised letter to Medline, who likewise sent a revised letter to customers. The revised letter contained additional information pertaining to the risk associated with the recalled product. If you have any questions, please contact the firm at 866-359-1704.
• Quantity in Commerce: 80 kits
• Distribution: Distributed to one account in Arkansas.
• 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.

• 510(K) Database: 510(K)s with Product Code = BTR and Original Applicant = SHERIDAN CATHETER CORP.; 510(K)s with Product Code = BTR and Original Applicant = Teleflex Medical, Inc.