Z-2149-2012Class II

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

Name: Z-2149-2012 Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform...
Creator: Apheresis Technologies, Inc.
Published: 2012-07-09
License: https://open.fda.gov/license/

Apheresis Technologies, Inc. / initiated 2012-07-09 / Terminated / root cause: manufacturing process

FDA source

Apheresis Technologies, Inc. began a recall of Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange on 2012-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2149-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-09
Posted: 2012-08-06
Terminated: 2013-12-16
Recalling firm: Apheresis Technologies, Inc.
Product: Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Product code: FIR Pump, Blood, Extra-Luminal
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: APHERESIS TECHNOLOGIES, INC. sent a letter dated July 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the device for repair. For questions customers should call 727-787-5616.
Quantity in commerce: 13
Distribution: Natonwide Distribution
Product codes and lots: D11003544 through D11003552 D11003556 through D11003558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2149-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2149-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-06

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)