FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1654-2012
- Recalling firm
- Apheresis Technologies, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-11-29
- Posted
- 2012-05-24
- Terminated
- 2012-05-25
- 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.
- Lot, serial or model codes
- Model PP-05; Serial Numbers E08003041, E08003042, E08003043, E08003044, and E08003045,
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FIR
- Firm FEI
- 1000113717
- Firm city
- Palm Harbor
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28