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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 May 23, 2014
Date Posted June 23, 2014
Recall Status1 Terminated 3 on January 13, 2016
Recall Number Z-1851-2014
Recall Event ID 68387
510(K)Number K935842  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH.

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.
Code Information Product Code: 102004040, Lot #13371, 13381, 13291, 13281, 13251 & 13231; Product Code: 102004050, Lot #13461, 13441, 13401, 13431, 13421, 13381, 13371, 1329, 13301, 13311, 13361, 13261, 13231, 13251 & 13241; Product Code: 102004060, Lot #13441, 13451, 13431, 13411, 13381, 13361, 13311, 13301, 13281, 13271, 13261, 13241 & 13231; Product Code: 102004070, Lot #13441, 13421, 13381, 13351, 13291, 13311, 13271 & 13261; Product Code: 102004070, Lot #13251 & 13241; and Product Code: 102004080, Lot #13371, 13301 & 13251.
Recalling Firm/
Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
Manufacturer Reason
for Recall
Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.
FDA Determined
Cause 2
Error in labeling
Action Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. 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 1658 ea
Distribution Nationwide Distribution and the country of Colombia.
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 = RUSCH, INC.