—#99649

Product

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.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K023918
Affected lot / code info: Catalog number: 121610 and 858510.

Why it was recalled

Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-04-04
Posted by FDA: 2011-06-29
Terminated: 2012-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99649. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.