FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1897-2009
- Recalling firm
- Apheresis Technologies, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-04-01
- Posted
- 2009-08-27
- Terminated
- 2010-07-06
- 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.
- Lot, serial or model codes
- Model PP-05; all units sold.
- 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