Recall Z-0044-2017 ยท JOH Tube Tracheostomy And Tube Cuff
Teleflex Medical
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
| Date | Oct 18, 2016 (initiated Aug 26, 2016) |
| Status | Terminated |
| Reason | The connector may disconnect from the tracheostomy tube during use. |
| Root cause | Use error |
| Action | Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service. For questions regarding this recall call 610-378-0131. |
| Quantity | 1095 units |
| Distribution | Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964056 | RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE Rusch Intl., Oct 10, 1997 |