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Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ...

FDA Recall #Z-0848-2014 — Class II — December 5, 2013

Recall #Z-0848-2014 Date: December 5, 2013 Classification: Class II Status: Terminated

Product Description

Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

Reason for Recall

Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

Recalling Firm

Maquet Cardiovascular Us Sales, Llc — Wayne, NJ

Classification

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

Product Type

Devices

Product Quantity

237 units

Distribution

Worldwide Distribution US, Canada and Japan.

Code Information

Part number 6481779

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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