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.
- Company
- Teleflex Medical
- Recall Initiated
- August 26, 2016
- Posted
- October 18, 2016
- Terminated
- March 21, 2017
- Recall Number
- Z-0044-2017
- Quantity
- 1095 units
- Firm Location
- Morrisville, NC
Reason for Recall
The connector may disconnect from the tracheostomy tube during use.
Distribution
Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
Lot / Code Info
Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
Root Cause
Use error
Action Taken
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.