FDA Medical Device Recalls (openFDA)
Apheresis Technologies, Inc.: Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
- Recall number
- Z-2149-2012
- Recalling firm
- Apheresis Technologies, Inc.
- Product
- Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
- Status
- Terminated
- Initiated
- 2012-07-09
- Posted
- 2012-08-06
- Terminated
- 2013-12-16
- 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
- Lot, serial or model codes
- D11003544 through D11003552 D11003556 through D11003558
- 510(k) numbers
- ["K961137"]
- 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