FDA Medical Device Recalls (openFDA)
Teleflex Medical: RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway.
- Recall number
- Z-2697-2011
- Recalling firm
- Teleflex Medical
- Product
- RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway.
- Status
- Terminated
- Initiated
- 2011-04-04
- Posted
- 2011-06-29
- Terminated
- 2012-03-02
- Reason
- Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.
- 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 orders.intl@teleflexmedical.com or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838
- Quantity
- 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.
- Lot, serial or model codes
- Catalog number: 121556
- 510(k) numbers
- ["K023918"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28