Z-2149-2012 Class II Terminated
FDA device recall Z-2149-2012 was initiated by Apheresis Technologies, Inc. on July 9, 2012 and is designated Class II. 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… The recall status is terminated (terminated December 16, 2013). Affected quantity: 13.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- July 9, 2012
- Termination Date
- December 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
Product Description
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
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.
Distribution Pattern
Natonwide Distribution
Code Information
D11003544 through D11003552 D11003556 through D11003558