Recall Z-2149-2012 ยท FIR Pump, Blood, Extra-Luminal
Apheresis Technologies, Inc.
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
| Date | Aug 6, 2012 (initiated Jul 9, 2012) |
| Status | Terminated |
| 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. |
| 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 | 13 |
| Distribution | Natonwide Distribution |
| 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 |