—#148176

Product

Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.

FDA product code: BYD — Condenser, Heat And Moisture (Artificial Nose)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Lots 201450, 201451, 201452, 201504

Why it was recalled

Cracks may occur at the 15mm and 22mm ISO female connector.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at fieldactions@maquet.com. For questions contact your local sales representative or Customer Service.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of FL, KS and WV.

Timeline

Recall initiated: 2015-12-03
Posted by FDA: 2016-08-09
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148176. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.