Apheresis Technologies, Inc.
Palm Harbor, FL, US
Apheresis Technologies, Inc. appears in FDA device records in Palm Harbor, FL. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Apheresis Technologies, Inc. between 1993 and 1996. The busiest year on record is 1993, with 1. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1996 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2149-2012 | Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange. | 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. | Class II | Terminated | |
| Z-1654-2012 | 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. | 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. | Terminated | ||
| Z-1897-2009 | 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. | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain