Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall Z-1897-2009 · Posted 2009-08-27
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Recalling FirmApheresis Technologies, Inc.
Recall StatusTerminated
Product CodeFIR
Date Initiated2009-04-01
Date Terminated2010-07-06
Product Quantity7 Owner's Manuals
Reason for Recall
Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.
Firm Action
PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution -- Florida, Colorado and Utah.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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