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U.S. Department of Health and Human Services

Class 3 Device Recall Sheridan Preformed Cuffed Oral Tracheal Tube 5.0 mm

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  Class 3 Device Recall Sheridan Preformed Cuffed Oral Tracheal Tube 5.0 mm see related information
Date Initiated by Firm September 27, 2006
Date Posted November 02, 2006
Recall Status1 Terminated 3 on August 12, 2009
Recall Number Z-0127-2007
Recall Event ID 36426
510(K)Number K822082  
Product Classification Tracheal Tube - Product Code BTR
Product Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210
Code Information catalog number (REF) 5-22210, lot number 1189023
Recalling Firm/
Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
Manufacturer Reason
for Recall
Biological indicator failed. Investigation eliminated all equipment and product related factors.
FDA Determined
Cause 2
Action Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Quantity in Commerce 830 units
Distribution Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
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.