FDAFDA · Food and drugs·Recall number Z-2149-2012
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Published August 15, 2012 · Recall initiated: July 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Apheresis Technologies, Inc.
- Distributor
- Natonwide Distribution
- Lot
- D11003544 through D11003552 D11003556 through D11003558
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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