Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No lab
FDA device recall Z-1897-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Apheresis Technologies, Inc.
- Reason for recall
- 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.
- Action taken
- PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- FIR
- Quantity affected
- 7 Owner's Manuals
- Distribution
- Nationwide Distribution -- Florida, Colorado and Utah.
- Date initiated
- 2009-04-01
- Date posted
- 2009-08-27
- Date terminated
- 2010-07-06
- Location
- Palm Harbor, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATI PLASMA PUMP (PP-04) (K961137) | Apheresis Technologies, Inc. | 1996-06-14 |