FDAClass IIAugust 15, 2012

Plasma Pump recall

Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

Why was Plasma Pump recalled?

On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.

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?

D11003544 through D11003552 D11003556 through D11003558

Product
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Recalling firm
Apheresis Technologies, Inc.
Quantity
13
Distribution
Natonwide Distribution
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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