CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
Plasma Pump recalled by Apheresis Technologies
Apheresis Technologies is recalling Plasma Pump. The recall was initiated on 9 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2149-2012
- FDA event ID
- 62563
- Recalling firm
- Apheresis Technologies, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2012
- FDA classified
- 6 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Jul 2012 | Recall initiated by company | |
| 6 Aug 2012 | Classified by FDA | +28 days |
| 15 Aug 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Where it was distributed
Natonwide Distribution
Questions about this recall
Is Plasma Pump recalled?
Yes. Apheresis Technologies recalled Plasma Pump on 9 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-2149-2012.
Why was it 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.
Which lots are affected?
D11003544 through D11003552 D11003556 through D11003558
Where was it sold?
Natonwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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