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U.S. Department of Health and Human Services

Class 3 Device Recall Sheridan SherIBronch Endobronchial Tube, LeftSided 37 Fr

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  Class 3 Device Recall Sheridan SherIBronch Endobronchial Tube, LeftSided 37 Fr 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-0125-2007
Recall Event ID 36426
510(K)Number K961977  
Product Classification Endobronchial Tube - Product Code BTS
Product Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16037
Code Information catalog (REF) number 5-16037, lot number 1188199
Recalling Firm/
Manufacturer		 Teleflex Medical
2345 Waukegan Rd Ste 120
Bannockburn IL 60015-1580
For Additional Information Contact Ms. Julie McDowell
610-948-2836
Manufacturer Reason
for Recall		 Biological indicator failed. Investigation eliminated all equipment and product related factors.
FDA Determined
Cause 2		 Other
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 175 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 = BTS and Original Applicant = KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
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