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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH Percutwist Set with Crystal Clear Sterile

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  Class 2 Device Recall RUSCH Percutwist Set with Crystal Clear Sterile see related information
Date Initiated by Firm April 04, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on March 02, 2012
Recall Number Z-2697-2011
Recall Event ID 58592
510(K)Number K023918  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product RUSCH Percutwist Set with Crystal Clear Sterile
Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway.
Code Information Catalog number: 121556
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Robert Z. Phillips
610-478-3138
Manufacturer Reason
for Recall		 Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an URGENT FIELD SAFETY NOTICE dated January 4, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for product, cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately. Customers were instructed to complete the field safety corrective action acknowledgement and stock status form and fax to their local Teleflex Medical Customer Service Sales Rep. If the customers did have stock from the affected lot number, they were to contact their local Teleflex Medical Customer Service/Sales Rep or distributor as indicated on the attached field safety corrective action acknowledgement and stock status form for a Return Autorization Number. Distributors were to communicate the field safety corrective action notice to their customers and forward the completed Acknoweldgement Form to orders.intl@teleflexmedical.com or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838
Quantity in Commerce see line 1.
Distribution Worldwide Distribution - Arabia, Asia, Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Ireland, Italy, Spain, Saudi Kuwait, Portugal, Russia Federation, Sweden, Slovenia and South America.
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 = JOH and Original Applicant = RUSCH INTL.
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