Data Foundry

Medical device recalls 2012

Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators… — Class II medical device recall Z-2149-2012

Terminated recall by Apheresis Technologies, Inc., reported 2012-08-15. On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a compla

Recall numberZ-2149-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmApheresis Technologies, Inc., Palm Harbor, FL, United States
Recall initiated2012-07-09
Classified2012-08-06
Reported by FDA2012-08-15
Terminated2013-12-16
Quantity13
Model numbersPP-04A

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2149-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.