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U.S. Department of Health and Human Services

Class 2 Device Recall SHERIDAN Endobronchial Tube

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  Class 2 Device Recall SHERIDAN Endobronchial Tube see related information
Date Initiated by Firm October 30, 2019
Create Date December 18, 2019
Recall Status1 Terminated 3 on September 30, 2021
Recall Number Z-0703-2020
Recall Event ID 84298
510(K)Number K851856  
Product Classification Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
Product HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Code Information Catalog: 5-16135; Manufacturing Lot: 73G1600257
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall		 The tracheal and brochial swivel connectors are incorrectly labeled.
FDA Determined
Cause 2		 Process control
Action An Urgent Medical Device Recall letter was sent to customers via FedEx 2-day service notifying consignees of the recall. Customers are asked to immediately discontinue use and quarantine any products with the affected product code and lot number identified in the letter. Consignees are asked to complete a Recall Acknowledgement Form and fax or email it to the recalling firm. Additional questions may be directed to Customer Service at 1-866-396-2111.
Quantity in Commerce 53 units
Distribution US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
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 = CBI and Original Applicant = SHERIDAN CATHETER CORP.
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