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U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI Sheridan SherIBronch Right Endobronchial Tube

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  Class 2 Device Recall Hudson RCI Sheridan SherIBronch Right Endobronchial Tube see related information
Date Initiated by Firm February 23, 2005
Date Posted April 06, 2005
Recall Status1 Terminated 3 on July 31, 2006
Recall Number Z-0681-05
Recall Event ID 31205
510(K)Number K851856  
Product Classification Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) - Product Code CBI
Product Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16137
Code Information catalog number (REF) 5-16137, lot numbers 1148460 and 1147062
Recalling Firm/
Manufacturer		 Teleflex Medical
2345 Waukegan Rd
Suite 120
Bannockburn IL 60015
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall		 The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.
FDA Determined
Cause 2		 Other
Action Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI.
Distribution Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.
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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