Recall Z-0044-2017
Teleflex Medical · initiated August 26, 2016
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
Reason for recall
The connector may disconnect from the tracheostomy tube during use.
FDA-determined 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.
Details
- Recall number
- Z-0044-2017
- Initiated
- August 26, 2016
- Posted by FDA
- October 18, 2016
- Terminated
- March 21, 2017
- Product code
- JOH – Tube Tracheostomy And Tube Cuff
- Quantity
- 1095 units
- Distribution
- Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
- Recalling firm
- Teleflex Medical, Morrisville, NC