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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch

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  Class 2 Device Recall Rusch see related information
Date Initiated by Firm December 02, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 29, 2014
Recall Number Z-0517-2012
Recall Event ID 60583
Product Classification Stylet, tracheal tube - Product Code BSR
Product Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia.

Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Code Information Catalog numbers: 502501, Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Robert Phillips
610-378-0131
Manufacturer Reason
for Recall		 Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
FDA Determined
Cause 2		 Pending
Action The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 73,281 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.
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.
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