Z-1654-2012

PlasmaPrO" Plasma Pump Model PP-05

Name: Z-1654-2012 PlasmaPrO" Plasma Pump Model PP-05
Creator: Apheresis Technologies, Inc.
Published: 2010-11-29
License: https://open.fda.gov/license/

Apheresis Technologies, Inc. / initiated 2010-11-29 / Terminated

FDA source

Apheresis Technologies, Inc. began a recall of PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma... on 2010-11-29. The reason FDA records is "Apheresis Technologies, Inc., Palm Harbor, FL, initiated a voluntarily withdrawal on November 29, 2010 of their five (5) units of the Plasma Pro Plasma Pump and later classified as a recall (removal) rather than a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1654-2012
Status: Terminated
Initiated: 2010-11-29
Posted: 2012-05-24
Terminated: 2012-05-25
Recalling firm: Apheresis Technologies, Inc.
Product: PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
Product code: FIR Pump, Blood, Extra-Luminal
Reason for recall: Apheresis Technologies, Inc., Palm Harbor, FL, initiated a voluntarily withdrawal on November 29, 2010 of their five (5) units of the Plasma Pro Plasma Pump and later classified as a recall (removal) rather than a withdrawal, Model # PP-05, Serial Numbers: E08003041, E08003042, E08003043, E08003044 and E08003045.
FDA root cause: PMA
Action: Apheresis Technologies sent a Letter by FedEx to their two consignees. The letter notified customers of the voluntary recall initiated, affected product and description of the problem. For questions call 727-784-2353 or 1-800-382-5556.
Quantity in commerce: 5 units
Distribution: US Nationwide Distribution including the states of Colorado and Utah.
Product codes and lots: Model PP-05; Serial Numbers E08003041, E08003042, E08003043, E08003044, and E08003045,

Product code FIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)