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Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture cond...

FDA Recall #Z-2374-2016 — Class II — December 3, 2015

Recall #Z-2374-2016 Date: December 3, 2015 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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

Recalling Firm

Teleflex Medical — Morrisville, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2,700 ea.

Distribution

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

Code Information

Lots 201450, 201451, 201452, 201504

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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