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Recall Observatory FDA recall evidence

Device product

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

Z-2149-2012

July 09, 2012

Class II

Product summary

Firm
Apheresis Technologies, Inc.
Event
Event 62563
Status
Terminated
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-2149-2012

Official wording

Reason: 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.

Code information: D11003544 through D11003552 D11003556 through D11003558

Distribution pattern: Natonwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.