RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.
This recall has been terminated (originally issued June 29, 2011).
- Company
- Teleflex Medical
- Recall Initiated
- April 4, 2011
- Posted
- June 29, 2011
- Terminated
- March 2, 2012
- Recall Number
- Z-2695-2011
- Quantity
- Total 328,727 for all units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
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.
Lot / Code Info
Catalog number: 121610 and 858510.
Root Cause
Other
Action Taken
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