Recall Z-2697-2011 ยท JOH Tube Tracheostomy And Tube Cuff
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.
| Date | Jun 29, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| 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 s |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023918 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS Rusch Intl., Mar 28, 2003 |