RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's tr

FDA device recall Z-2697-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

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

Root cause

Other

Status

Terminated

Product code

JOH

Quantity affected

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

Date initiated

2011-04-04

Date posted

2011-06-29

Date terminated

2012-03-02

Location

Durham, NC

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