Recall Z-1654-2012 ยท FIR Pump, Blood, Extra-Luminal
Apheresis Technologies, Inc.
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.
| Date | May 24, 2012 (initiated Nov 29, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | PMA |
| Action | Apheresis Technologies sent a Letter by FedEx to their two consignees. The letter notified customers of the voluntary recall initiated, affected product and description of the problem. For questions call 727-784-2353 or 1-800-382-5556. |
| Quantity | 5 units |
| Distribution | US Nationwide Distribution including the states of Colorado and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.