—#149196

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.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K964056
Affected lot / code info: Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491

Why it was recalled

The connector may disconnect from the tracheostomy tube during use.

Root cause (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.

Timeline

Recall initiated: 2016-08-26
Posted by FDA: 2016-10-18
Terminated: 2017-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149196. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.