FDAClass IIJune 15, 2016

The Plum 360 is a large volume infuser capable of recall

The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The…

Why was The Plum 360 is a large volume infuser capable of recalled?

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.

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?

PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.

Product
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The…
Recalling firm
Hospira Inc.
Quantity
1490 infusion pumps.
Distribution
U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
Recall date
June 15, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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