Recall Z-2149-2012— Apheresis Technologies, Inc.

Name: FDA recall Z-2149-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-09

Class II · Terminated

Class II FDA medical device recall by Apheresis Technologies, Inc., initiated 2012-07-09, terminated 2013-12-16. It names one FDA 510(k) clearance: K961137. Product: Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.. 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..

Recalling firm: Apheresis Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-09
Terminated: 2013-12-16
Firm location: Palm Harbor, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K961137 — ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc.·cleared 1996-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.