Z-2696-2011

RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea...

Name: Z-2696-2011 RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea...
Creator: Teleflex Medical
Published: 2011-04-04
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-04-04 / Terminated

FDA source

Teleflex Medical began a recall of RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway on 2011-04-04. The reason FDA records is "Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2696-2011
Status: Terminated
Initiated: 2011-04-04
Posted: 2011-06-29
Terminated: 2012-03-02
Recalling firm: Teleflex Medical
Product: RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
FDA root cause: Other
Action: 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 [email protected] or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838
Quantity in commerce: see line 1.
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.
Product codes and lots: Catalog number: 121502

Product code JOH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)