FDAClass IAugust 1, 2012

Alaris PC unit recall

Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

Why was Alaris PC unit recalled?

The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

not available

Product
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Recalling firm
CareFusion 303, Inc.
Quantity
112,912 units total (106,888 units in US)
Distribution
US Nationwide Distribution
Recall date
August 1, 2012
Classification
Class I
Status
Terminated
Agency
FDA (device)
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