Z-1897-2009

Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor...

Name: Z-1897-2009 Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor...
Creator: Apheresis Technologies, Inc.
Published: 2009-04-01
License: https://open.fda.gov/license/

Apheresis Technologies, Inc. / initiated 2009-04-01 / Terminated / root cause: labeling and UDI

FDA source

Apheresis Technologies, Inc. began a recall of Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi... on 2009-04-01. The reason FDA records is "Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1897-2009
Status: Terminated
Initiated: 2009-04-01
Posted: 2009-08-27
Terminated: 2010-07-06
Recalling firm: Apheresis Technologies, Inc.
Product: Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
Product code: FIR Pump, Blood, Extra-Luminal
Reason for recall: Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.
Quantity in commerce: 7 Owner's Manuals
Distribution: Nationwide Distribution -- Florida, Colorado and Utah.
Product codes and lots: Model PP-05; all units sold.

Product code FIR

K961137Class IIAti Plasma Pump (Pp-04)Apheresis Technologies, Inc. / cleared 1996-06-14

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)