Reported Aug 15, 2012 · Terminated
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform…
Apheresis Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apheresis Technologies, Inc. · 612 Florida Ave · Palm Harbor, FL · 34683-5459
Is this the product you have?
- Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
- Lot codes and dates
- D11003544 through D11003552 D11003556 through D11003558
- Amount recalled
- 13
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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