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Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner ...

FDA Recall #Z-0534-2014 — Class I — December 5, 2013

Recall #Z-0534-2014 Date: December 5, 2013 Classification: Class I Status: Terminated

Product Description

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

Reason for Recall

CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

Recalling Firm

CareFusion 303, Inc. — San Diego, CA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

4824 total units (4242 units in US)

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.

Code Information

not available

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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