FDAClass IIJuly 12, 2017

Alaris PC Unit recall

Alaris PC Unit, Model 8015

Why was Alaris PC Unit recalled?

BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

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?

Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.

Product
Alaris PC Unit, Model 8015
Recalling firm
CareFusion 303, Inc.
Quantity
568,283 units
Distribution
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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