Recall Z-1897-2009 ยท FIR Pump, Blood, Extra-Luminal
Apheresis Technologies, Inc.
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.
| Date | Aug 27, 2009 (initiated Apr 1, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 7 Owner's Manuals |
| Distribution | Nationwide Distribution -- Florida, Colorado and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961137 | ATI PLASMA PUMP (PP-04) Apheresis Technologies, Inc., Jun 14, 1996 |