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U.S. Department of Health and Human Services

Class 1 Device Recall Rusch TracheoFlex Tracheostomy Tube

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 Class 1 Device Recall Rusch TracheoFlex Tracheostomy Tubesee related information
Date Initiated by FirmAugust 26, 2016
Date PostedOctober 18, 2016
Recall Status1 Terminated 3 on March 21, 2017
Recall NumberZ-0044-2017
Recall Event ID 75053
510(K)NumberK964056 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductWilly Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Code Information Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information ContactAlice K. Harper
610-378-0131
Manufacturer Reason
for Recall		The connector may disconnect from the tracheostomy tube during use.
FDA Determined
Cause 2		Use error
ActionTeleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service. For questions regarding this recall call 610-378-0131.
Quantity in Commerce1095 units
DistributionWorldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JOH
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