• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Sheridan Endotracheal Tube

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Sheridan Endotracheal Tube see related information
Date Initiated by Firm June 07, 2019
Date Posted July 30, 2019
Recall Status1 Open3, Classified
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 2
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 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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.
510(K)s with Product Code = BTR and Original Applicant = Teleflex Medical, Inc.
-
-