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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 Tube see related information
Date Initiated by Firm August 26, 2016
Date Posted October 18, 2016
Recall Status1 Terminated 3 on March 21, 2017
Recall Number Z-0044-2017
Recall Event ID 75053
510(K)Number K964056  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Willy 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
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Alice 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
Action Teleflex 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 Commerce 1095 units
Distribution Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
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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