Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic
FDA device recall Z-2149-2012 · posted 2012-08-06 · Terminated
Recall details
- Recalling firm
- Apheresis Technologies, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FIR
- Quantity affected
- 13
- Distribution
- Natonwide Distribution
- Date initiated
- 2012-07-09
- Date posted
- 2012-08-06
- Date terminated
- 2013-12-16
- Location
- Palm Harbor, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATI PLASMA PUMP (PP-04) (K961137) | Apheresis Technologies, Inc. | 1996-06-14 |