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MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunti...

FDA Recall #Z-2683-2016 — Class II — December 3, 2015

Recall #Z-2683-2016 Date: December 3, 2015 Classification: Class II Status: Terminated

Product Description

MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

Reason for Recall

Cracking 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 units

Distribution

US Distribution to the states of : FL, KS, and WV.

Code Information

Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 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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